# REGISTRATION 2517-141

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### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

OffiCE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES
April 6, 2011 Kelly R. Hoskins Sergeant's Pet Care Products, Inc. 2625 South 158" Plaza Omaha, NE 68130 Subject: CSF Notification(s) for Pesticide Registration Notice 98-10

Dear: Kelly Hoskins:
The Agency is in receipt ofyour Application for Pesticide Notification under Pesticide RegistrationNotice (PRN) 98-10 dated March 24, 2011 for the following product(s). Sergeant's Fipronil 

### +Nylar Squeeze-On for Dogs (EPA Reg. No. 2517-141)
The Registration Division (RD) has conducted a review ofthis request for its applicability under PRN 98-10 and finds that the action(s) requested fall within the scope ofPRN 98-10. The Confidential Statement ofFormula (CSF) andlor label submitted with the application has (have) been stamped ''Notification'' and will be placed in'ourrecords.
Ifyou have any questions, please contact Regina Foushee'-Smith at 703-605-0780. Sincerely""

## ~t/. 

# /,. Ai

# C'j{ce~~/**L(lc2,:Aj~** Richard Oebken Product Manager Insecticide Branch Registration Division 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

OffiCE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES
April 6, 2011 Kelly R. Hoskins Sergeant's Pet Care Products, Inc. 2625 South 158" Plaza Omaha, NE 68130 Subject: CSF Notification(s) for Pesticide Registration Notice 98-10

Dear: Kelly Hoskins:
The Agency is in receipt ofyour Application for Pesticide Notification under Pesticide RegistrationNotice (PRN) 98-10 dated March 24, 2011 for the following product(s). Sergeant's Fipronil 

### +Nylar Squeeze-On for Dogs (EPA Reg. No. 2517-141)
The Registration Division (RD) has conducted a review ofthis request for its applicability under PRN 98-10 and finds that the action(s) requested fall within the scope ofPRN 98-10. The Confidential Statement ofFormula (CSF) andlor label submitted with the application has (have) been stamped ''Notification'' and will be placed in'ourrecords.
Ifyou have any questions, please contact Regina Foushee'-Smith at 703-605-0780. Sincerely""

## ~t/. 

# /,. Ai

# C'j{ce~~/**L(lc2,:Aj~** Richard Oebken Product Manager Insecticide Branch Registration Division

# o~Sergeant's Pet Care Products, Inc. 2625 South 15Bth Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax402.938.7091 • www.sergeants.com



### March 24, 2011 Richard Gebken, PMI0 Office ofPesticide Programs (7504P) U.S. Environmental Protection Agency DocumentProcessing Desk (NOTIF) Room S-4900, One Potomac Yard 2777 South Crystal Dtive Arlington, VA 22202 Subject: Notification SubmissionperPRNotice 98-10 to Add an Alternate #2 CSF for Sergeant's Fipronil 

### +Nylar Squeeze-On for Dogs (EPA Registration Number 2517-141) DearMr. Gebken: Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 158ili 

### Plaza, Omaha, NE 68130- 1770, EPA CompanyNumber2517) is submitting a notificationpursuantto PRNotice 98-10 to add an alternate formulation #2 and newFormulator's Exemption Statement to supportthe registration ofSergeant's Fipronil 

### +Nylar Squeeze-On for Dogs (EPA Registration Number 2517-141). Please find enclosed the following documentation in support ofthis registration:

• Cover letter (this document);

• Applicationfor Registration (EPA Form 8570-1);

• Copy ofCurrent EPA Approved Confidential Statement ofFormulas (Basic and Alternate #1);

• Copy ofthe new proposedAlternate #2 CSF Formulation (two copies); and

• UpdatedFormulator's Exemption Statement (EPAForm 8570-27).

does not change the toxicological category orchemical properties ofthe product. Further, this notification does notrequire any change to the current EPA approved label language. This notification is consistentwith the provisions ofthe PRNotice 98-10 and EPA regulations at40 CFR 152.46, and no other changes have been made to the labeling orthe confidential statement offonnulaofthis product. I understand that it is a violation of18 U.S.C. Sec. 1001 to willfully make any false statementto EPA. I further understandthat if this notification is not consistentwith the terms ofPRNotice 98-10 and40 CFR 152.46, this productmay be in violation ofFIFRA and I may be subjectto enforcement action and penalties under sections 12 and 14 ofFIFRA. Sergeant's Pet Care Products, Inc.

2625 South 15Bth Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax402.938.7091 • www.sergeants.com



### March 24, 2011 Richard Gebken, PMIO Office ofPesticide Programs (7504P) U.S. Environmental Protection Agency DocumentProcessing Desk (NOTIF) Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202 Subject: Notification SubmissionperPRNotice 98-10 to Add an Alternate #2 CSF for Sergeant's Fipronil 

### +Nylar Squeeze-On for Dogs (EPA Registration Number 2517-141) DearMr. Gebken: Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 158th 

### Plaza, Omaha, NE 68130- 1770, EPA CompanyNumber2517) is submitting a notificationpursuantto PRNotice 98-10 to add an alternate formulation #2 and newFormulator's Exemption Statement to supportthe registration ofSergeant's Fipronil 

### +Nylar Squeeze-On for Dogs (EPA Registration Number 2517-141). Please find enclosed the following documentation in support ofthis registration:

• Cover letter (this document);

• Applicationfor Registration (EPA Form 8570-1);

• Copy ofCurrent EPA Approved Confidential Statement ofFormulas (Basic and Alternate #1);

• Copy ofthe new proposedAlternate #2 CSF Formulation (two copies); and

• UpdatedFormulator's Exemption Statement (EPAForm 8570-27).

does not change the toxicological category orchemical properties ofthe product. Further, this notification does notrequire any change to the current EPA approved label language. This notification is consistentwith the provisions ofthe PRNotice 98-10 and EPA regulations at40 CFR 152.46, and no other changes have been made to the labeling orthe confidential statement offormula ofthis product. I understand that it is a violation of18 U.S.C. Sec. 1001 to willfully make any false statementto EPA. I further understandthat if this notification is not consistentwith the terms ofPRNotice 98-10 and40 CFR 152.46, this productmay be in violation ofFIFRA and I may be subjectto enforcement action and penalties under sections 12 and 14 ofFIFRA.

### sergeant's Pet

### CareProducts, Inc. 2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 4D2.938.7091 • www.sergean1s.com 

### Please note infonnation found in this letter and enclosures is considered 

### CONFIDENTIAL BUSINESSINFORMATIONand must notbe released to any party outside ofEPA. Ifyou have any questions regarding this submission, please contactme at402-938-7079. Sincerely,

# ~, Manager ofRegulatory Affairs Sergeant's Pet Care Products, Inc. Enclosures

cc: RosannaLouie-Juzwiak, EPA sergeant's PetCare Products, Inc.

2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergean1s.com 

### Please note infonnation found in this letter and enclosures is considered 

### CONFIDENTIAL BUSINESSINFORMA TIONand must notbe released to any party outside ofEPA. Ifyou have any questions regarding this submission, please contact me at402-938-7079. Sincerely,

# ~, Manager ofRegulatory Affairs Sergeant's Pet Care Products, Inc. Enclosures

cc: RosannaLouie-Juzwiak, EPA0531 98 d OMB N 2070 0060 A AF I ti fi b , 

# " Plea<:e read' " rns ruc ons on reverse e ore comp e ng orm. 

## "m pprove o. 

## - pprova expires


### - - Uniled Stales 

# D Registration OPP Idenlifier Number 

# EPA Environmental Protection Agency 

# o Amendment Washinglon, DC 20460 

## r;;:g Other Application for Pesticide

- Section I


# ,. Company/Produc1 Number 2. EPA Produc1 Manager 3. Proposed Classificalion 2517-141 Richard Gebk.en 4. Company/Produc1 (Name) PM# 10

### ~None DReslric1ed Sergeanl's Pel Care Producls. Inc. I Sergeanl's Fipronil + Nylar SqueezeOn For DOQS 5. Name and Address ofApplicanl (Include liP Code) 6. Expedited Review. In accordance with FIFRA Sec1ion 3{C)(3)(b)(1), my Sergeant's Pet Care Products, Inc. produc1 is similar or idenlical in composilion and labeling 10: 2625 South 15S1h Plaza 

## NOTIFICATION Omaha, NE 68130-1770 EPA Reg. No. Product Name 

### APK 

### ti LUi
D Check ifIhis is a new address Section II 

# o Amendment

- Explain below. 

# o Final prinled labels in response 10 Agency letter daled XX-XX-XX 

# o Resubmission in response 10 Agency letter daled XX-XX·XX 

# o "Me Too" Applicalion Notification

- Explain below. 

# D Olher

- Explain below. Explanalion: Use addilional page(s) if necessary. (For section I and Section 11.) Submission ofAlternate #2 Confidential Statement of Formula and a Formulator's Exemption as a Notification Pursuant to PR Notice 98·10. Section III 1. Malerial This Product Will Be Packaoed In: Child-Resistanl Packaging Unil Packaging Waler Soluble Packaging 2. Type of Conlainer l'Zl Yes· 

### c><J y" DYes DMelal ONo 

# o No 

### c><J No l'Zl Plaslic If"Yes" No. per If"Yes" No. per DGlaSS *Certification must Unil Packaging wgl. Container Package wgl. Conlainer DPaper be submitted 0.023 fl 02 (0.67 ml) 0.045 fl 02 (J .34 mil 3 vials 

## I DOl her (SpeCify) Plaslic Bag 0.091 fl 02 (2.68 ml) 0.136 fl 02 (4.02 ml) 3. Localion ofNel Conlenls Information 4, Size(s) Relail Container 5. Localion of Label Directions k:S]Label D Conlainer 0.017 fl 02 (0.50ml) Don Label [2JOn Labeling accompanying producl 6. Manner in Which Label is Affixed 10 Product DLithograPh l'Zlolher DPaper glued DSlenciled Section IV 

# ,. Conlac1 Poinl (Complete rlems directlv belowforidentification ofirtdividual to be conlacled, ifnecessary. 10 process fhis applicalion.) Name Tille Telephone No. (Include Area Code) Kelly R. Hosk.ins Manager of RegulaloryAffairs 402938·7079 Certification 6 Date Application I certify Ihallhe slalemenls I have made on this form and all allachmenls thereto are lrue, accurale and complele. I Received acknowledge Ihal any knowingly false or misleading slatement may be punishable byfine or imprisonmenl or bolh (Stamped) under applicable law.

## ~yS;90al"" )( 

# Ii/Uk 3. Tille Manager of Regulalory Affairs 4, Typed Name: f Kelly R. Hdskins 5. Dale: 0312412011 0531 98 d OMB N 2070 0060 A AF I ti fi b , 

# " Plea<:e read' " rns ruc ons on reverse e ore comp e ng orm. 

## "m pprove o. 

## - pprova expires


### - - Uniled Stales 

# D Registration OPP Idenlifier Number 

# EPA Environmental Protection Agency 

# o Amendment Washinglon, DC 20460 

## r;;:g Other Application for Pesticide

- Section I


# ,. Company/Produc1 Number 2. EPA Produc1 Manager 3. Proposed Classificalion 2517-141 Richard Gebk.en 4. Company/Produc1 (Name) PM# 10

### ~None DReslric1ed Sergeanl's Pel Care Producls. Inc. I Sergeanl's Fipronil + Nylar SqueezeOn For DOQS 5. Name and Address ofApplicanl (Include liP Code) 6. Expedited Review. In accordance with FIFRA Sec1ion 3{C)(3)(b)(1), my Sergeant's Pet Care Products, Inc. produc1 is similar or idenlical in composilion and labeling 10: 2625 South 15S1h Plaza 

## NOTIFICATION Omaha, NE 68130-1770 EPA Reg. No. Product Name 

### APK 

### ti LUi
D Check ifIhis is a new address Section II 

# o Amendment

- Explain below. 

# o Final prinled labels in response 10 Agency letter daled XX-XX-XX 

# o Resubmission in response 10 Agency letter daled XX-XX·XX 

# o "Me Too" Applicalion Notification

- Explain below. 

# D Olher

- Explain below. Explanalion: Use addilional page(s) if necessary. (For section I and Section 11.) Submission ofAlternate #2 Confidential Statement of Formula and a Formulator's Exemption as a Notification Pursuant to PR Notice 98·10. Section III 1. Malerial This Product Will Be Packaoed In: Child-Resistanl Packaging Unil Packaging Waler Soluble Packaging 2. Type of Conlainer l'Zl Yes· 

### c><J y" DYes DMelal ONo 

# o No 

### c><J No l'Zl Plaslic If"Yes" No. per If"Yes" No. per DGlaSS *Certification must Unil Packaging wgl. Container Package wgl. Conlainer DPaper be submitted 0.023 fl 02 (0.67 ml) 0.045 fl 02 (J .34 mil 3 vials 

## I DOl her (SpeCify) Plaslic Bag 0.091 fl 02 (2.68 ml) 0.136 fl 02 (4.02 ml) 3. Localion ofNel Conlenls Information 4, Size(s) Relail Container 5. Localion of Label Directions k:S]Label D Conlainer 0.017 fl 02 (0.50ml) Don Label [2JOn Labeling accompanying producl 6. Manner in Which Label is Affixed 10 Product DLithograPh l'Zlolher DPaper glued DSlenciled Section IV 

# ,. Conlac1 Poinl (Complete rlems directlv belowforidentification ofirtdividual to be conlacled, ifnecessary. 10 process fhis applicalion.) Name Tille Telephone No. (Include Area Code) Kelly R. Hosk.ins Manager of RegulaloryAffairs 402938·7079 Certification 6 Date Application I certify Ihallhe slalemenls I have made on this form and all allachmenls thereto are lrue, accurale and complele. I Received acknowledge Ihal any knowingly false or misleading slatement may be punishable byfine or imprisonmenl or bolh (Stamped) under applicable law.

## ~yS;90al"" )( 

# Ii/Uk 3. Tille Manager of Regulalory Affairs 4, Typed Name: f Kelly R. Hdskins 5. Dale: 0312412011Form approved. OMS No. 2070-0060, 2070-0057, 2070-0t07, 2070-0t22, 2070-0164. 

# a EPA
United States Environmental Protection Agency Washington, DC 20460 Formulator's Exemption Statement (40 CFR 152.85)
Applicant's Name and Address EPA File Symbol/Registration Number Sergeant's Pet Care Products, Inc. 2517-141 2625 South 158th Plaza Product Name Omaha, NE 68130 Sergeant's Fipronil 

### +Nylar Squeeze-0n for Dogs
Date ofConlidential Statement of Formula (EPA Form 8570-4) 03/24/2011 As an authorized representative ofthe applicant for registration ofthe product identified above, I certify that: (1) This product contains the tollowing active ingredient(s): Fipronil (9.8%) Pyriproxyfen (2.0%)

(2) Ofthese. each active ingredient listed in paragraph (4) is present solely as the result ofthe use ofthat active ingredient in the manufacturirrg, formulation or repackaging another product which contains that active ingredient which is registered under FIFRA Section 3, is purchased by us from another person and meets the requirements of40 CFR section 158.50(e)(2) or (3). (3) Indicate by checking (A) or (6) belowwhich paragraph applies:

71 (A) An accurate Confidential Statement of Formula (EPA FORM 8570-4) for the above identified prodUct is allached to this statement, That formula statement indicates. by company name, registration number. and product name, the source ofthe active irrgredient(s) listed in paragraph (1), OR "I (8) The Confidential Statement of Formula (CSF)(EPA Form 8570-4) referenced above and on file with**t~1e** Er;A "s comple,&: cUI,'en!, an accurate and contains the information required on the current CSF, (4) The following active ingredients in this product qualify for the formulator's exemption.

Source Active Ingredient Product Name Registratior**I~UmUl;:r** Fipronil Fipronil Fipronil Pyriproxyfen 

# S19'::V r!

# II/'Ii Name and Title Date Kelly R. Hoskins, Manager 

# " 03/24/2011 EPA Form 857 • .,. ,.., '. n n ,..,

## -_

# ... nn. py pp py Form approved. OMS No. 2070-0060, 2070-0057, 2070-0t07, 2070-0t22, 2070-0164.

py pppy 

# a EPA
United States Environmental Protection Agency Washington, DC 20460 Formulator's Exemption Statement (40 CFR 152.85)
Applicant's Name and Address EPA File Symbol/Registration Number Sergeant's Pet Care Products, Inc. 2517-141 2625 South 158th Plaza Product Name Omaha, NE 68130 Sergeant's Fipronil 

### +Nylar Squeeze-0n for Dogs

Date ofConlidential Statement of Formula (EPA Form 8570-4) 03/24/2011 As an authorized representative ofthe applicant for registration ofthe product identified above, I certify that: (1) This product contains the tollowing active ingredient(s): Fipronil (9.8%) Pyriproxyfen (2.0%)

(2) Ofthese. each active ingredient listed in paragraph (4) is present solely as the result ofthe use ofthat active ingredient in the manufacturirrg, formulation or repackaging another product which contains that active ingredient which is registered under FIFRA Section 3, is purchased by us from another person and meets the requirements of40 CFR section 158.50(e)(2) or (3). (3) Indicate by checking (A) or (6) below which paragraph applies:

71 (A) An accurate Confidential Statement of Formula (EPA FORM 8570-4) for the above identified prodUct is allached to this statement, That formula statement indicates. by company name, registration number. and product name, the source ofthe active irrgredient(s) listed in paragraph (1), OR 

# , (8) The Confidential Statement of Formula (CSF)(EPA Form 8570-4) referenced above and on file with**t~1e** Er;A "s comple,&: cUI,'en!, an accurate and contains the information required on the current CSF, (4) The following active ingredients in this product qualify for the formulator's exemption.

Source Active Ingredient Product Name Registratior**I~UmUl;:r** Fipronil Fipronil Fipronil Pyriproxyfen 

# Sl9'gj,/II/'Ii Name and Title Date Kelly R. Hoskins, Manager 

# " 03/24/2011 EPA Form 8579 7 {R"'.

# O'l"" Copy t EPA C, 2 -A licant coU.S. ENVIRONMENTAL PROTECTION AGENCY OfficeofPesticidePrograms Rcgistrll1ion Division (7504P) 1200 PennsylvaniaAve., N.W.

Washing)on, D.C. 20460 EPA Registration No.

2517-141 Date ofIssuance: 

### MAR 2 3 2011

NOTICE OF PESTICIDE, 0' Registration D Reregistration (under the Federal Insecticide, Fungicide, and Rodenticide Act, as amended)

Name and Address ofRegistrant (include ZIP Code): Sergeant's Pet Care Products, Inc. c/o Exponent, Inc. 2625 South 15Sth Plaza Omaha, NE 68130 Term ofIssuance: Conditional Registration Time-limited: see conditions below Name ofPesticideProdUCl: Sergeant's Fipronil 

### + Nylar Squeeze-on for Dogs

Not" do to 'he ,hove "V",'v

Onthe basis ofinfonnation furnished by the registrant, the above namedpesticide is hereby registered underthe Federal Insecticide, Fungicide and Rodenticide Act. Registration is in no way to be construed as an endorsement or recommendation ofthis product bythe Agency. In orderto protecthealth and the environment, the Administrator, on his motion, may at any time suspend or cancel the registration ofa pesticide in accordance with the Act. The acceptance ofany name in connection with the registration ofa productunderthis Act is not to be construed as giving the registrant a right to exclusive use ofthe name orto its use ifithas been covered by others. This product is conditionally registered in accordance with FIFRA §3(c)(7)(a) provided that:
1. This registration is**time~limited** and expires two years from the date this product is first released for shipment.
You must provide the Agency with a projected release for shipment date within 30 days ofthe date ofthis Notice ofRegistration. The Agency will calculate the expiration date based on the projected release for shipment date until an actual release for shipment date is provided in writing.
2. Consider limiting the fonnulations ofeach productto one basic confidential statement offonnula. The Agency may require this in the future. It is possible that no additional alternate fonnulations or minor fonnulation amendments will be approved for this product in the future.
3. As a condition ofregistration for this product, within one year from**t~e** date ofthis registration, you must submit the results ofStorage Stability and Corrosion Characteristics studies, corresponding to OCSPP Guidelines 830.6317 and 830.6320, respectively, including interim reDorts made at 0 3,6 9 and 12 month intervals.
Page 1 of5 U.S. ENVIRONMENTAL PROTECTION AGENCY OfficeofPesticidePrograms Rcgistrll1ion Division (7504P) 1200 PennsylvaniaAve., N.W.

Washing)on, D.C. 20460 EPA Registration No.

2517-141 Date ofIssuance: 

### MAR 2 3 2011

NOTICE OF PESTICIDE: 0' Registration D Reregistration (under the Federal Insecticide, Fungicide, and Rodenticide Act, as amended)
Name and Address ofRegistrant (include ZIP Code): Sergeant's Pet Care Products, Inc. c/o Exponent, Inc. 2625 South 15Sth Plaza Omaha, NE 68130 Term ofIssuance: Conditional Registration Time-limited: see conditions below Name ofPesticideProdUCl: Sergeant's Fipronil 

### +Nylar Squeeze-on for Dogs

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..·.·• i.'.""""'·"""""'" '. Onthe basis ofinfonnation furnished by the registrant, the above namedpesticide is hereby registered underthe Federal Insecticide, Fungicide and Rodenticide Act. Registration is in no way to be construed as an endorsement orrecommendation ofthis productbythe Agency. In orderto protecthealth and the environment, the Administrator, on his motion, may at anytime suspend or cancel the registrationofapesticide in accordance with the Act. The acceptance ofany name in connection with the registration ofaproductunderthis Act is not to be construed as giving the registrant aright to exclusive use ofthe name orto its use ifithas been covered by others. This productis conditionally registered in accordance with FIFRA §3(c)(7)(a) provided that: 1. This registration is**time~limited** and expires two years from the date this product is first released for shipment. You must provide the Agency with a projected release for shipment date within 30 days ofthe date ofthis Notice ofRegistration. The Agency will calculate the expiration date based on the projected release for shipment date until an actual release for shipment date is provided in writing. 2. Consider limitingthe fonnulations ofeach productto one basic confidential statement offonnula. The Agency may require this in the future. It is possible that no additional alternate fonnulations or minor fonnulation amendments will be approved for this product in the future. 3. As a condition ofregistration for this product, within one year from**t~e** date ofthis registration, you must submitthe results ofStorage Stability and Corrosion Characteristics studies, corresponding to OCSPP Guidelines 830.6317 and 830.6320, respectively, including interim reports made at 0,3,6,9, and 12 month intervals.
Page 1 of54. Within one year ofthe date on this Notice ofRegistration, and priorto formulating this product, you must provide the Agency the following:

a. The registration number and establishment number ofthe manufacturing or technical product(s) from which the active ingredient is derived. b. The name and address ofthe entity from which the manufacturing product(s) was obtained; and c. A copy ofthe bill ofsale for this manufacturing product(s). 5. Within 30 days from the date ofthis registration, in accordance with FIFRA §3(c)(l)(F) and 3(c)(2)(B), you must submit a copy ofall offers to pay compensation and evidence oftheir delivery, used to support the data required for this product 6. You must submit quarterly enhanced incident reports and quarterly sales information in doses sold for this product for the quarter that begins on April 1, 2011. The quarterly reports are due two months after each quarter ends. Please flag any Confidential Business Information as such. Enhanced incident reporting should be submitted to the Product Manager. Quarterly sales information should be submitted to the Registration Division (7504P), to the Product Manager's attention. The following is a list ofinfonnation that must be included in the quarterly reports for each incident: EPA Registration Number Product name (brand name) Lot# Where purchased: internet, store, veterinarian Active Ingredient(s) Weight range for product
Date on which incident occurred. (mm/dd/yyyy) State in which the incident occurred. (standard 2 letter abbreviation) Registrantcase # Species: dog, cat, other (specify) Breed: (as reported by pet owner) Age: months or years Sex: M, F, or neutered Weight pounds Primary Route ofExposure: dermal, oral, other animal, inhalation, other Body System: neurological, dermatological, GI, respiratory, ocular, other Major signs noted with separate column for each sign, using standard terminology Time to Onset (hours, days) Treated by veterinarian: yes or no Firsttime product used: yes or no Misuse: use on incorrect species, overdose, too frequent dosing, other (describe) Any known precondition EPA Severity Code: death, major, moderate, minor Outcome: died, recovered, still treated, unknown Page 2 of5 4. Within one year ofthe date on this Notice ofRegistration, and priorto formulating this product, you must provide the Agency the following:

a. The registration number and establishment number ofthe manufacturing or technical product(s) from which the active ingredient is derived. b. The name and address ofthe entity from which the manufacturing product(s) was obtained; and c. A copy ofthe bill ofsale for this manufacturing product(s). 5. Within 30 days from the date ofthis registration, in accordance with FIFRA §3(c)(l)(F) and 3(c)(2)(B), you must submit a copy ofall offers to pay compensation and evidence oftheir delivery, used to support the data required for this product 6. You must submit quarterly enhanced incident reports and quarterly sales information in doses sold for this product for the quarter that begins on April 1, 2011. The quarterly reports are due two months after each quarter ends. Please flag any Confidential Business Information as such. Enhanced incident reporting should be submitted to the Product Manager. Quarterly sales information should be submitted to the Registration Division (7504P), to the Product Manager's attention. The following is a list ofinfonnation that must be included in the quarterly reports for each incident: EPA Registration Number Product name (brand name) Lot# Where purchased: internet, store, veterinarian Active Ingredient(s) Weight range for product
Date on which incident occurred. (mm/dd/yyyy) State in which the incident occurred. (standard 2 letter abbreviation) Registrantcase # Species: dog, cat, other (specify) Breed: (as reported by pet owner) Age: months or years Sex: M, F, or neutered Weight pounds Primary Route ofExposure: dermal, oral, other animal, inhalation, other Body System: neurological, dermatological, GI, respiratory, ocular, other Major signs noted with separate column for each sign, using standard terminology Time to Onset (hours, days) Treated by veterinarian: yes or no Firsttime product used: yes or no Misuse: use on incorrect species, overdose, too frequent dosing, other (describe) Any known precondition EPA Severity Code: death, major, moderate, minor Outcome: died, recovered, still treated, unknown Page 2 of57. Along with the enhanced incidentreporting, you must submit an analysis ofthe incidents seen, to include the following details: All incidents should be reported including all minor dermal and ocular irritation reports. Summary table for dogs showing number ofincidents ofeach severity code for each route ofexposure. Each incident should only be reported once. Ifone incident has several routes ofexposure, the order should be ocular> oral> dermal. In other words, an incident with both oral and dermal exposure would be reported as oral exposure, and an incident with both ocular and oral exposure would be reported as ocular exposure. A similar summary table for cats (misuse or secondary exposure) showing number of incidents ofeach severity code for each route ofexposure. Summary table for dogs and table for cats showing number ofincidents that are believed due to secondary exposure (e.g.,**nU1lti~pet** households). A summary table for dogs showing number ofincidents for each severity code for these age ranges: <3 months,**3~6** months,**6~9** months, 9-12 months, I yr, 2 yr, 3 yr, 4 yr, 5 yr, 6 yr, 7 yr, 8 yr, 9 yr, 10 yr, II yr, 12 yr, 13 yr, 14 yr, IS yr, >IS yr. A summary table showing the number ofdog incidents for each severity code for each pet weight range on the product label.
A summary table for dog weight showing number ofincidents for each product weight range. This table should show number ofincidents in dogs weighing less than that product weight range, number ofincidents in dogs in lower halfofweight range, number ofincidents in dogs in upper halfofweight range, and dogs weighing more than the product weight range. Table showing number ofincidents for each dog breed. Table showing number ofincidents in dogs for each clinical sign. Table showing number ofincidents in dogs for each organ system. Report aggregate incidents, but do not combine moderate and minor incidents. 8. You must submit and/or cite all data reql1ired for registration ofyour product under FIFRA §3(c)(5) when the Agency requires all registrants ofsimilar products to submit such data, and submit acceptable responses required for reregistration ofyour product under FIFRA §4.

All labeling comments below are in reference to the proposed master label, dated March 10. 20II. These comments apply to all submitted draft labeling, including the master labeL the color**mock~up** labels. and the proposed text and graphics for the stickers and magnet: 9. Thr011ghout the entire label, per the Acute Toxicity and Companion Animal Safety review, change "up to 22 Ibs" to "4 to 22 lbs" to include the lowest weight range. 1O. On page 1 under the header Fleas, revise the following claims to add the underlined words, or Page 3 of5 7. Along with the enhanced incidentreporting, you must submit an analysis ofthe incidents seen, to include the following details: All incidents should be reported including all minor dermal and ocular irritation reports. Summary table for dogs showing number ofincidents ofeach severity code for each route ofexposure. Each incident should only be reported once. Ifone incident has several routes ofexposure, the order should be ocular> oral> dermal. In other words, an incident with both oral and dermal exposure would be reported as oral exposure, and an incident with both ocular and oral exposure would be reported as ocular exposure. A similar summary table for cats (misuse or secondary exposure) showing number of incidents ofeach severity code for each route ofexposure. Summary table for dogs and table for cats showing number ofincidents that are believed due to secondary exposure (e.g.,**nU1lti~pet** households). A summary table for dogs showing number ofincidents for each severity code for these age ranges: <3 months,**3~6** months,**6~9** months, 9-12 months, I yr, 2 yr, 3 yr, 4 yr, 5 yr, 6 yr, 7 yr, 8 yr, 9 yr, 10 yr, II yr, 12 yr, 13 yr, 14 yr, IS yr, >IS yr. A summary table showing the number ofdog incidents for each severity code for each pet weight range on the product label.
A summary table for dog weight showing number ofincidents for each product weight range. This table should show number ofincidents in dogs weighing less than that product weight range, number ofincidents in dogs in lower halfofweight range, number ofincidents in dogs in upper halfofweight range, and dogs weighing more than the product weight range. Table showing number ofincidents for each dog breed. Table showing number ofincidents in dogs for each clinical sign. Table showing number ofincidents in dogs for each organ system. Report aggregate incidents, but do not combine moderate and minor incidents. 8. You must submit and/or cite all data reql1ired for registration ofyour product under FIFRA §3(c)(5) when the Agency requires all registrants ofsimilar products to submit such data, and submit acceptable responses required for reregistration ofyour product under FIFRA §4.

All labeling comments below are in reference to the proposed master label, dated March 10. 20II. These comments apply to all submitted draft labeling, including the master labeL the color**mock~up** labels. and the proposed text and graphics for the stickers and magnet: 9. Thr011ghout the entire label, per the Acute Toxicity and Companion Animal Safety review, change "up to 22 Ibs" to "4 to 22 lbs" to include the lowest weight range. 1O. On page 1 under the header Fleas, revise the following claims to add the underlined words, or Page 3 of5delete struck-out words (because the submitted data do not supportthese claims), as follows: "[ResearcH E!efl'l0nstrates that [branE! name] kills adult fleas, flea eggs, and flea larvae anE! prevents pupae for more up to three fl'lonths.]" "[Prevents all flea stages, flea eggs, flea pupae, and flea larvae.]" "[Kills flea eggs [larvae] preYents [pupae] for more than [63 days] [9 weeks]]" ''[Kills Flea for Up to [4 weeks!] [2 months] [3 months]]"
II. On pages I and 2 under Multiple Infestations, revise the following claims to add the underlined words, or delete struck-out words, as follows: "[Kills fleas, ticks, mosquitoes, chewing lice, flea eggs, and larvae and prevents pupae]" ''[Kills Flea Eggs & Flea Larvae for up to more tHan [63 days], [9 weeks]!]" "[Kills all stages ofthe flea life cycle]" "[Prevents and controls reinfestations oflisted pests for up to [I month] [4 weeks]]" I2. On pages 2 and 3 under All Others, revise the following claims to add the underlined words, or delete struck-out words, as follows: "[Controls flea reinfestation for up to [3 months] [12 weeks]]" "[[Free] BrochHre Inside!]" "[[Free] Brochure anE! Calendar Stickers Inside]" "[Pre,,'ents and controls reinfestations oflisted pests]" "[[Free with purchase] [Free inside] Monthly Application Reminder [Magnet] [e+if:l] [eaffi]]" 13. On page 3, delete the statement "[Ingredient Statement may be on front or back label]" because the ingredient statement must be placed on the Front Panel. 14. On page 3 in the Ingredients Statement, all Inert ingredients must be identified when electing to listthe inert ingredients. 15. On page 5 in the How to Apply section, correct the reapplication interval from "4 weeks" to "30 days" to be consistent with the interval stated under Frequency ofApplication. 16. On pages 5 and 6 under the Frequency ofApplication, add the underlined words and delete the struck-out text in the following statement: "[Studies show that] [branE! name] kills fleas (in as little as 1 hour) for up to three months]." "[Brand name] kills mosquitoes within 24 hours for up to the first 7 days after treatment, then within 48 hours for up to 28 days]." 17. On page 6 under the Storage and Disposal statement, replace "Container Handling" with "ContainerDisposal." 18. On page 6 in the Warranty statement, remove the brackets within the paragraph so that ifused, the Warranty statement is present in its entirety. 19. On page 8 under the End-back/side Panel section, delete the "Optional Insert or Package Copy" statement because the Agency has not reviewed the optional insert as part ofthe labeling for approvaL 20. Note that should au wish to add areference to the com any's website on your label, thenthe Page40f5 delete struck-out words (because the submitted data do not supportthese claims), as follows: "[ResearcH E!efl'l0nstrates that [branE! name] kills adult fleas, flea eggs, and flea larvae anE! prevents pupae for more up to three fl'lonths.]" "[Prevents all flea stages, flea eggs, flea pupae, and flea larvae.]" "[Kills flea eggs [larvae] preYents [pupae] for more than [63 days] [9 weeks]]" ''[Kills Flea for Up to [4 weeks!] [2 months] [3 months]]"
II. On pages I and 2 under Multiple Infestations, revise the following claims to add the underlined words, or delete struck-out words, as follows: "[Kills fleas, ticks, mosquitoes, chewing lice, flea eggs, and larvae and prevents pupae]" ''[Kills Flea Eggs & Flea Larvae for up to more tHan [63 days], [9 weeks]!]" "[Kills all stages ofthe flea life cycle]" "[Prevents and controls reinfestations oflisted pests for up to [I month] [4 weeks]]" I2. On pages 2 and 3 under All Others, revise the following claims to add the underlined words, or delete struck-out words, as follows: "[Controls flea reinfestation for up to [3 months] [12 weeks]]" "[[Free] BrochHre Inside!]" "[[Free] Brochure anE! Calendar Stickers Inside]" "[Pre,,'ents and controls reinfestations oflisted pests]" "[[Free with purchase] [Free inside] Monthly Application Reminder [Magnet] [e+if:l] [eaffi]]" 13. On page 3, delete the statement "[Ingredient Statement may be on front or back label]" because the ingredient statement must be placed on the Front Panel. 14. On page 3 in the Ingredients Statement, all Inert ingredients must be identified when electing to listthe inert ingredients. 15. On page 5 in the How to Apply section, correct the reapplication interval from "4 weeks" to "30 days" to be consistent with the interval stated under Frequency ofApplication. 16. On pages 5 and 6 under the Frequency ofApplication, add the underlined words and delete the struck-out text in the following statement: "[Studies show that] [branE! name] kills fleas (in as little as 1 hour) for up to three months]." "[Brand name] kills mosquitoes within 24 hours for up to the first 7 days after treatment, then within 48 hours for up to 28 days]." 17. On page 6 under the Storage and Disposal statement, replace "Container Handling" with "ContainerDisposal." 18. On page 6 in the Warranty statement, remove the brackets within the paragraph so that ifused, the Warranty statement is present in its entirety. 19. On page 8 under the End-back/side Panel section, delete the "Optional Insert or Package Copy" statement because the Agency has not reviewed the optional insert as part ofthe labeling for approvaL 20. Note that should au wish to add areference to the com any's website on your label, thenthe Page40f5website becomes labeling under FlFRA and is subject to review by the Agency. Ifthe website content is false or misleading, the product would be deemed misbranded and unlawful to sell or distribute under FIFRA § 12(a)(I)(E). 40 CFR 156. IO(a)(5) list examples ofstatements EPA may consider false or misleading. In addition, regardless ofwhether a website is referenced on your product's label, claims made on the website may not substantially differ from those claims approved through the registration process. Therefore, should the Agency find or ifit is broughtto our attention that a website contains false or misleading statements, or claims substantially differing from the EPA-approved registration, the website may be referred to the EPA's Office of Enforcement and Compliance Assurance. 21. Revise the EPA Registration Number to read: "EPA RegistrationNo.**2517~141."** Ifthe Agency determines that future mitigation measures are necessary for all pet spot-on products, you will be infonned, and be expected to comply. Ifmitigation measures are necessary, the Agency may take appropriate regulatory actions. Two copies ofthe finished labeling must be submitted prior to releasing the product for shipment. Ifthese conditions are not complied with, the registration will be subjectto cancellation in accordance with FIFRA sec. 6(e). Your release for shipment ofthe product constitutes acceptance ofthese conditions. A copy ofyour label stamped "Accepted with Comments" is enclosed for your records. Please contact Rosanna**Louie~Juzwiak** at (703) 308-0037 with any questions.
Enclosure: Sergeant's Fipronil 

### +Nylar Squeeze-on for Dogs Label, StampedAcceptedwith Comments Signature ofApproving Official: 

# &LL (lJJeRichard Gebken, ProductManager(10) Registration Division, Insecticide Branch
EPA Form 8570_6

Page 5 of5 Date: 

### MAR 23 2011 website becomes labeling under FlFRA and is subject to review by the Agency. Ifthe website content is false or misleading, the product would be deemed misbranded and unlawful to sell or distribute under FIFRA § 12(a)(I)(E). 40 CFR 156. IO(a)(5) list examples ofstatements EPA may consider false or misleading. In addition, regardless ofwhether a website is referenced on your product's label, claims made on the website may not substantially differ from those claims approved through the registration process. Therefore, should the Agency find or ifit is broughtto our attention that a website contains false or misleading statements, or claims substantially differing from the EPA-approved registration, the website may be referred to the EPA's Office of Enforcement and Compliance Assurance. 21. Revise the EPA Registration Number to read: "EPA RegistrationNo.**2517~141."** Ifthe Agency determines that future mitigation measures are necessary for all pet spot-on products, you will be infonned, and be expected to comply. Ifmitigation measures are necessary, the Agency may take appropriate regulatory actions. Two copies ofthe finished labeling must be submitted prior to releasing the product for shipment. Ifthese conditions are not complied with, the registration will be subjectto cancellation in accordance with FIFRA sec. 6(e). Your release for shipment ofthe product constitutes acceptance ofthese conditions. A copy ofyour label stamped "Accepted with Comments" is enclosed for your records. Please contact Rosanna**Louie~Juzwiak** at (703) 308-0037 with any questions.
Enclosure: Sergeant's Fipronil 

### +Nylar Squeeze-on for Dogs Label, StampedAcceptedwith Comments Signature ofApproving Official: 

# &LL (lJJeRichard Gebken, ProductManager(10) Registration Division, Insecticide Branch
EPA Form 8570_6

Page 5 of5 Date: 

### MAR 23 201110 March 201 1 Information in [ ] is optional. 

# Sergeant's® MasterLabel Version 10.1 EPA Reg. No. 25 17-RUR Page lof9

[Apply to puppies over 12 weeks old] [Apply to puppies 12 weeks or older] [ABNs] [(Sergeant's®) (Sentry®) FRONTIER GOLD (Spot On) for dogs] [(Sergeant's') (Sentry') EetoadvanceTM (Spot On) for dogs]

[Option text appears in brackets-the final product label may include some or all ofthe optional text on front, back or side panels. The CRP required text will not change.] 

## Sergeant's Fipronil 

# + Nylar Squeeze-On for Dogs ACCEPTED with 

### CoMMENTS In 

### EPALetterDated: 

### MAR 2 3 2011 Underthe Federal Insecticide Fungicide, 800 RodenticideAct: asamended, for the pesticide registered under 

# 4lA Reg. No. 2517-/ 

### [Mosquitoes] 

### [0Kills mosquitoes] [within 24 hours for up to 7 days] [ood within 48 hours for up to 28 days] [oKills mosquitoes] [Fleas] [eR"search 

### demonstrates that [brand name] kills adult fleas, flea eggs, and flea laryae and prevents pupae for up to three months.] [o[brood naroe] prevents development ofall flea stages for up to [63 days] [9 weeks].] [·Prevents all flea stages (adult fleas, flea eggs, flea pupae and flea larvae)] [. Ifdog is at high riskfor flea reinfestation a once a month application may be needed] [oKills flea eggs [larvae] [pfe,'enls pupae] for more than [63 days][9 weeks]] [oWith Nylar® Insect Growth Regulator which Breaks the Flea Life Cycle] 

### [0With Nylar® to Break FleaLife Cycle] [oWith Insect Growth Regulatorto Break Flea Life Cycle] [oDual Action 

### [I]: Fipronil with Nylar® lGR Effectively Breaks the FleaLife Cycle] [oDual Action 

### [I]: Effectively Breaks the Flea Life Cycler!]] [oKills Fleas for Up to [4 weeks!] [2 months] [3 months]] [Multiple Infestations] [oFlea & Tick Control for Dogs & Puppies 12 Weeks Old ood Older] [-Kills fleas, flea eggs, ticks, chewing lice & mosquitoes] [-Kills fleas, ticks, mosquitoes, chewing lice, flea eggs, and larvae and prevents pupae] [-Monthlyflea, tick, mosquito, chewing lice, and flea egg protection] [-Monthly flea, tick, mosquito and chewing lice protection] [-Kills fleas, ticks, mosquitoes, flea eggs, and chewing lice] 

### [0[4 Week] [Flea ood Tick & Treatment]] 

### [0 [Seven] [7] Way [Action] [Effectiveness] [Control] to kill fleas, ticks, [mosquitoes,] chewing lice, flea eggs, flea larvae [&] [and] prevent the development offlea pupae]] 

### [0 [Six] [6] Way [Action] [Effectiveness] [Control] to kill fleas, ticks, [mosquitoes,] 10 March 2011 Information in [ ] is optional.

[Apply to puppies over 12 weeks old] [Apply to puppies 12 weeks or older] [ABNs] [(Sergeant's®) (Sentry®) FRONTIER GOLD (Spot On) for dogs]**[(Sergeant's~ (Sentry~**  EctoadvanceTM (Spot On) for dogs] 

# Sergeant's® Master Label Version 10.1 EPA Reg. No. 25 17-RUR Page 10f9



## Sergeant's Fipronil 

# + Nylar Squeeze-On for Dogs ACCEPTED with COMMENTS InEPALetterDated: 

## MAR 2 3 2011 Underthe Federal Insecticide Fungicide, 800 RodenticideAct: as amended, for the pesticide registered under 4lA Reg. No. 2517-/ [Mosquitoes] [-Kills mosquitoes] [within 24 hours for up to 7 days] [and within 48 hours for up to 28 days] [-Kills mosquitoes] [Fleas] [-R"search demonstrates that [brand name] kills adult fleas, flea eggs, and flea laryae and prevents pupae for up to three months.] [-[brand name] prevents development ofall flea stages for up to [63 days] [9 weeks].] [-Prevents all flea stages (adult fleas, flea eggs, flea pupae and flea larvae)] [- Ifdog is at high riskfor flea reinfestation a once a month application may be needed] [-Kills flea eggs [larvae] [prevents pupae] for more than [63 days] [9 weeks]] [-With Nylar® Insect Growth Regulator which Breaks the Flea Life Cycle] [-With Nylar® to Break FleaLife Cycle] [-With Insect Growth Regulatorto Break Flea Life Cycle] [-Dual Action [!]: Fipronil with Nylar® lOREffectively Breaks the FleaLife Cycle] [-Dual Action [!]: Effectively Breaks the Flea Life Cycle[!]] [-Kills Fleas for Up to [4 weeks!] [2 months] [3 months]] [MultipIe Infestations] [-Flea & Tick Control for Dogs & Puppies 12 Weeks Old and Older] [-Kills fleas, flea eggs, ticks, chewing lice & mosquitoes] [-Kills fleas, ticks, mosquitoes, chewing lice, flea eggs, and larvae and prevents pupae] [-Monthlyflea, tick, mosquito, chewing lice, and flea egg protection] [-Monthly flea, tick, mosquito and chewing lice protection] [-Kills fleas, ticks, mosquitoes, flea eggs, and chewing lice] [-[4 Week] [Flea and Tick & Treatment]] [- [Seven] [7] Way [Action] [Effectiveness] [Control] to kill fleas, ticks, [mosquitoes,] chewing lice, flea eggs, flea larvae [&] [and] prevent the development offlea pupae]] [- [Six] [6] Way [Action] [Effectiveness] [Control] to kill fleas, ticks, [mosquitoes,]

# Sergeant's® Master Label 10 March 2011 Version 10.1 EPA Reg. No. 2517-RUR 

### Information in [ ] is optional. Page 2 of9 chewing lice, flea eggs [&] [and] flea larvae] ['[Four (4) Week] [Flea, Tick, Mosquito and Chewing Lice Control] ['Kills Flea Eggs & Flea Larvae for up to fRo,e than [63 days], [9 weeks]!] 

### [-Prevents Flea Eggs From Developing Into BitingAdults] ['Kills 

### all stages ofthe flea life cycle] ['Kills Fleas, Ticks, Flea Eggs & Flea Larvae for up to 4 Weeks] 

### [-4 week Flea and Tick Treatment!] 

### [Once A Month Flea and Tick Treatment] [-Kills Fleas and Ticks for up to 4 weeks!] [-When used monthly [brand name] completely breaks the flea life cycle and controls tick and chewing lice infestations.] 

### [-Prevents and controls reinfestations oflisted pests for up to [1 month] [4 weeks]] [Ticks] 

### [-Kills ticks including those that maytransmit Lyme disease] [-Kills American Dog Ticks [(Dermacentor variabilis)] 

### for up to 4 weeks!] ['Kills Ticks for Up to [4 weeks] 

### I] 

### [-Kills [all stages ofJ Deer Ticks (vector ofLyme 

### Disease) for up to 4 weeks] [·Kills Ticks (Including Deer Ticks) for up to 4 weeks] [·Kills [Brown], [American,] [and Lone Star ]Dog Ticks for up to 4 weeks] 

### [-Kills Rhipicephalus sanguineus 

### for up to 4 weeks] [All Others] 

### [-For Dogs and Puppies 12 weeks ofage or older] ['ForDogs 

### ["I'

## ±to 221bs], [23-441bs], [45-88 lbs], [89-1321bs] 

### [-Controls flea reinfusta-tion for 

### up to [3 months] [12 vieeks]] [·Fast Acting] ['Waterproof] [.Long Lasting] ['Apply monthly] 

### [-A once montWy application is required for chewing lice.] [Apply monthly to control chewing lice.] 

### [-Rapid elimination ofchewing lice infestations] [-Controls mites that may cause sarcoptic mange] [·Three Applications] and/or [3 Month Supply] or [12 Week Supply]] 

### [-Best ifused 

### year round!] ['(lCON Showing 4 WeekProtection)] [,4 Week Dose!] ['1 Month Dose!] [·Easy to Use Application] 

### [-Specially Fonnulated for Dogs and Puppies over 12 weeks old] [·[Free] Calendar Stickers Inside!] 

### [·fF

..e] BfOchffie Inside!] 

### [-[Free] 

### Broehure and Calendar Stickers Inside] ['Patented Technology] ['Apply once every [4 weeks] [month]!] 

### [-Effective after bathing and exposure to water and sunlight] 

# Sergeant's® Master Label 10 March 2011 Version 10.1 EPA Reg. No. 2517-RUR 

### Information in [ ] is optional. Page 2 of9 chewing lice, flea eggs [&] [and] flea larvae] ['[Four (4) Week] [Flea, Tick, Mosquito and Chewing Lice Control] ['Kills Flea Eggs & Flea Larvae for up to fRo'e than [63 days], [9 weeks]!] 

### [-Prevents Flea Eggs From Developing Into BitingAdults] ['Kills 

### all stages ofthe flea life cycle] ['Kills Fleas, Ticks, Flea Eggs & Flea Larvae for up to 4 Weeks] 

### [-4 week Flea and Tick Treatment!] 

### [Once A Month Flea and Tick Treatment] [-Kills Fleas and Ticks for up to 4 weeks!] [-When used monthly [brand name] completely breaks the flea life cycle and controls tick and chewing lice infestations.] 

### [-Prevents and controls reinfestations oflisted pests for up to [1 month] [4 weeks]] [Ticks] 

### [-Kills ticks including those that maytransmit Lyme disease] [-Kills American Dog Ticks [(Dermacentor variabilis)] 

### for up to 4 weeks!] ['Kills Ticks for Up to [4 weeks] 

### I] 

### [-Kills [all stages ofJ Deer Ticks (vector ofLyme 

### Disease) for up to 4 weeks] [·Kills Ticks (Including Deer Ticks) for up to 4 weeks] [·Kills [Brown], [American,] [and Lone Star ]Dog Ticks for up to 4 weeks] 

### [-Kills Rhipicephalus sanguineus 

### for up to 4 weeks] [All Others] 

### [-For Dogs and Puppies 12 weeks ofage or older] ['ForDogs 

### ["I'

## ±to 221bs], [23-441bs], [45-88 lbs], [89-1321bs] 

### [-Controls flea reinfusta-tion for 

### up to [3 months] [12 vieeks]] [·Fast Acting] ['Waterproof] [.Long Lasting] ['Apply monthly] 

### [-A once montWy application is required for chewing lice.] [Apply monthly to control chewing lice.] 

### [-Rapid elimination ofchewing lice infestations] [-Controls mites that may cause sarcoptic mange] [·Three Applications] and/or [3 Month Supply] or [12 Week Supply]] 

### [-Best ifused 

### year round!] ['(lCON Showing 4 WeekProtection)] [,4 Week Dose!] ['1 Month Dose!] [·Easy to Use Application] 

### [-Specially Fonnulated for Dogs and Puppies over 12 weeks old] [·[Free] Calendar Stickers Inside!] 

### [·fF

..e] BfOchffie Inside!] 

### [-[Free] 

### Broehure and Calendar Stickers Inside] ['Patented Technology] ['Apply once every [4 weeks] [month]!] 

### [-Effective after bathing and exposure to water and sunlight]

# Sergeant's® Master Label 10 March 2011 Vcrsion10.! EPA Reg. No. 2517-RUR Infonnation in [ ] is optional. Page 3 of9 [-Prevents and controls reinfestations oflisted pests] [-[Free with purchase] [Free inside] Monthly Application Reminder [Magnet] 

### [€lip] leaN]] [-3 applications] [-Fiponil (9.8%) 

### + [pyrproxyfen] [Nylar®] (2.0%)] [-US and Foreign patents pending] 

### [-Lift [here] for more information] [-For year round protection, apply (brand name) monthly] [3 Applications] [For use ONLY on dogs] 

### [Yj> 

### :1: to 22 Ibs] [23-44Ibs] [45-88Ibs] [89-1321bs] [over 12 weeks ofage] [ForDogs & Puppies (12 weeks or older and)] [and]lup 1014 to 22 1bs.] [ForDogs 23-44 Ibs.] [ForDogs 45-881bs.] [ForDogs 89-132 1bs.] 

### [ ) - Denotes Optional Statements and/or Images that May be Used on Front, Back or Side Label Panels [Ingredient Statement may be on 

### frSHt or back label]
ACTIVE INGREDIENTS: 

### Fipronil 9.8% 

### Pyriproxyfen 2.00/0 OTHER INGREDIENTS 

### *: 88.2% TOTAL: ...............................•................................... 100.0% 

### [*diethylene glycol monoethyl ether] [Nylar® is a registered trademark ofMcLaughlin Gormley King Company. U.S. PatentNo. 5,942,525]
KEEP OUT OF REACH OF CHILDREN 

### WARNING See [Back] [or][Side] [Label Panel[s] for Additional Precautionary Statements
NET CONTENTS: Contains (3) [0.023 

### fl oz] [0.67 ml] applicators Contains (3) [0.045 

### fl oz] [1.34 m1] applicators Contains (3) [0.091 

### fl oz] [2.68 ml] applicators Contains (3) [0.136 

### fl oz] [4.02 m1] applicators 

# Sergeant's® Master Label 10 March 2011 Vcrsion10.! EPA Reg. No. 2517-RUR Infonnation in [ ] is optional. Page 3 of9 [-Prevents and controls reinfestations oflisted pests] [-[Free with purchase] [Free inside] Monthly Application Reminder [Magnet] 

### [€lip] leaN]] [-3 applications] [-Fiponil (9.8%) 

### + [pyrproxyfen] [Nylar®] (2.0%)] [-US and Foreign patents pending] 

### [-Lift [here] for more information] [-For year round protection, apply (brand name) monthly] [3 Applications] [For use ONLY on dogs] 

### [Yj> 

### :1: to 22 Ibs] [23-44Ibs] [45-88Ibs] [89-1321bs] [over 12 weeks ofage] [ForDogs & Puppies (12 weeks or older and)] [and]lup 1014 to 22 1bs.] [ForDogs 23-44 Ibs.] [ForDogs 45-881bs.] [ForDogs 89-132 1bs.] 

### [ ) - Denotes Optional Statements and/or Images that May be Used on Front, Back or Side Label Panels [Ingredient Statement may be on 

### frSHt or back label]
ACTIVE INGREDIENTS: 

### Fipronil 9.8% 

### Pyriproxyfen 2.00/0 OTHER INGREDIENTS 

### *: 88.2% TOTAL: ...............................•................................... 100.0% 

### [*diethylene glycol monoethyl ether] [Nylar® is a registered trademark ofMcLaughlin Gormley King Company. U.S. PatentNo. 5,942,525]
KEEP OUT OF REACH OF CHILDREN 

### WARNING See [Back] [or][Side] [Label Panel[s] for Additional Precautionary Statements
NET CONTENTS: Contains (3) [0.023 

### fl oz] [0.67 ml] applicators Contains (3) [0.045 

### fl oz] [1.34 m1] applicators Contains (3) [0.091 

### fl oz] [2.68 ml] applicators Contains (3) [0.136 

### fl oz] [4.02 m1] applicatorsVersion 10.1 Page 4 of9 

# Sergeant's® Master Label EPA Reg. No. 25l7-RUR [is optional. 10 March 2011 Information in [

[BACK/SIDE CARTON LABEL

- MASTERLABEL] 

### [brand name] contains fipronil and the insect growth regulator (IGR) Nylar® to effectively kill fleas, ticks [(including those that may transmit Lyme Disease)], and kill[s] flea eggs, flea larvae, mosquitoes and chewing lice. The active ingredients in [brand name] feature a sustained release formula developed for fast acting [and long lasting] control offleas, ticks, [mosquitoes] and chewing lice for up to [1 month] [[4] [four] weeks] on dogs.
READ ENTIRE LABEL BEFORE EACH USE. USE ONLY ON DOGS AND PUPPIES OVER 12 WEEKS OF AGE. PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS. WARNING. Causes substantial buttemporary eye injury. Do not get in eyes or on clothing. Harmful ifswallowed. Harmful ifabsorbed through skin. Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals. Wash hands thoroughly with soap and water afterhandling and before eating, drinking, chewing gum, using tobacco, orusing the toilet. Remove and wash contaminated clothing before reuse. HAZARDS TO DOMESTIC ANIMALS. Forexternal use only. Do not use on puppies under 12 weeks ofage. Individual sensitivities, while rare, may occur after using any pesticide product. [Some dogs may experience temporary startle effects when any productis applied.] Dogs may experience some temporary irritation at the site ofproduct application. Ifsigns persist, or become more severe within a few days ofapplication, consult a veterinarian immediately. 

### Ifyour dog has an unusual reaction to the initial application, consult a veterinarian before repeating treatment. Certain medications can interact with pesticides. Consult a veterinarian before using on medicated, pregnant, nursing, debilitated or aged dogs. Call 1-800-781-4738 for 24-hour assistance.
FIRST AID



### IfIn Eyes 

# • Hold eye open and rinse slowly and gently with water for 15-20 minutes. 

# • Remove contact lenses, ifpresent, afterthe first 5 minutes, then continue rinsing eye. 

# • Call a poison control centeror doctor for furthertreatment advice. 

### IfOn Skin 

# • Take offcontaminated clothing. Or Clothing 

# • Rinse skin immediately with plenty ofwaterfor 15-20 minutes. 

# • Call apoison control centeror doctor fortreatment advice. 

### IfSwallowed 

# • Call a poison control centeror doctor immediately for treatment advice. 

# • Have person sip a glass ofwater ifableto swallow. 

# • Do not induce vomiting unless told to do so by a poison control centeror doctor. 

# • Do not give anything bv mouth to an unconscious person. HOT LINE NUMBER Have the productcontaineror label with you when calling a poison control centeror doctor, or going fortreatment. Formore infonnation on this pesticide product (including health concerns, medical emergencies orpesticide incidents), you may call 1-800-781-4738. NOTE TO PHYSICIAN OR VETERINARIAN Treat patient symptomatically 

# Sergeant's® Master Label 10 March 2011 Version 10.1 EPA Reg. No. 25l7-RUR Infonnation in [ [is optional. Page 4 of9

### RRQNY!i&\R~N',g!J:~?',Wmj\:i'm$1'!t0'@;;:"\T ::M 

### '/i"/"::,/:i'ii,":,',,'!:'Li:2,,,,:}}I{;':: :;X":/:!,:',:i':'::,";".';H'!,

### :':L:i:gg,~i;:~,R!!~,~~~':g~**~JgHQNJ~~~A.R** [BACK/SIDE CARTON LABEL

- MASTERLABEL] [brand name] contains fipronil and the insect growth regulator (IGR) Nylar® to effectively kill fleas, ticks [(including those that may transmit Lyme Disease)], and kill[s] flea eggs, flea larvae, mosquitoes and chewing lice. The active ingredients in [brand name] feature a sustained release fonnula developed for fast acting [and long lasting] control offleas, ticks, [mosquitoes] and chewing lice for up to [1 month] [[4] [four] weeks] on dogs.
READ ENTIRE LABEL BEFORE EACH USE. USE ONLY ON DOGS AND PUPPIES OVER 

### 12 WEEKS OF AGE. PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS. WARNING. Causes substantial buttemporary eye injury. Do not get in eyes oron clothing. Harmful ifswallowed. Hannful ifabsorbed through skin. Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals. Wash hands thoroughly with soap and water afterhandling and before eating, drinking, chewing gum, using tobacco, orusing the toilet. Remove and wash contaminated clothing before reuse. HAZARDS TO DOMESTIC ANIMALS. Forexternal use only. Do notuse on puppies under 12 weeks ofage. Individual sensitivities, while rare, may occur afterusing any pesticide product. [Some dogs may experience temporary startle effects when any productis applied.] Dogs may experience some temporary irritation atthe site ofproduct application. Ifsigns persist, or become more severe within a few days ofapplication, consult a veterinarian immediately. 

### Ifyour dog has an unusual reaction to the initial application, consult a veterinarianbefore repeating treatment. Certain medications can interact with pesticides. Consult a veterinarianbefore using on medicated, pregnant, nursing, debilitated or aged dogs. Call 1-800-781-4738 for 24-hour assistance.
FIRST AID



### IfIn Eyes 

# • Hold eye open and rinse slowly and gently with water for 15-20 

### minutes.


# • Remove contact lenses, ifpresent, afterthe first 5 

### minutes, then continue rinsing eye. 

## • Call apoison control centerordoctor for furthertreatment advice. 

### IfOn Skin 

## • Take offcontaminated clothing. Or Clothing 

# • Rinse skin immediately with plenty ofwaterfor 15-20 

### minutes. 

# • Call apoison control centerordoctor fortreatment advice. 

### IfSwallowed 

# • Call a poison control centeror doctor immediately for treatment advice. 

# • Have person sip a glass ofwater ifableto swallow. 

# • Do not induce vomiting unless told to do so by apoison control centerordoctor. 

# • Do not give anything by mouth to an unconscious person. HOT LINE NUMBER Have the productcontaineror label with 

### you when calling apoison control centerordoctor, orgoing fortreatment. Formore information on this pesticide product (including health concerns, medical emergencies orpesticide incidents), you may call 1-800-781-4738. NOTE TO PHYSICIAN OR VETERINARIAN 

### Treat patient symptomaticallyVersion 10.1 Page 5 of9 

# Sergeant's® Master Label EPA Reg. No. 25 I7-RUR 

### ] is optional. 10 March 2011 Information in [
DIRECTIONS FORUSE It is a violation ofFederal law to use this product in a manner inconsistent with its labeling. DO NOT ALLOW CHILDREN TO APPLY PRODUCT. TO PREVENT HARM TO YOU AND YOUR DOG, READ ENTIRE LABEL BEFORE EACH USE. FOLLOW ALL DIRECTIONS AND PRECAUTIONARY STATEMENTS CAREFULLY. FOR EXTERNAL USE ON DOGS ONLY. DO NOT USE ON RABBITS. DO NOT USE ON OTHER ANIMALS. DO NOT USE ON CATS. May be toxic and potentially fatal ifapplied to or ingested by cats. FOREXTERNAL USE ON DOGS ONLY. Do not use on puppies under 12 weeks ofage. Weigh your dog to be sure you are applying the 

### right dose formulated for the weight ofyour dog. Do nottreat your dog with more than one pesticide product at a time. Over dosing your dog can 

### result in serious illness and even death. Best if

### used year round. Certainmedications can interact 

### with pesticides. Consult a veterinarian before using this product on debilitated, aged, medicated, pregnant, or nursing dogs. Consult a veterinarian before using on dogs with known organ dysfunction. DO NOT USE ON CATS or animals other than dogs. Separate the treated dog from all other dogs and cats for 24 hours after treatmenthas been applied. Cats and dogs that actively groom orengage in close physical contactwith treated dog may be at risk ofserious hannful effects. The most common signs ofingestion are excessive salivation and foaming at the mouth. Ifthese symptoms occur immediately feed your dog and continue to monitor your dog for the next 24 hours. Ifsymptoms persist call 1-800-781-4738 to talk to a veterinarian. Cats exhibiting these same symptoms from ingestion should be taken to the veterinarian immediately. Ifyour dog is exhibiting signs ofand/or are being treated for skin dermatitis, talk to your vet before applying any topical flea and tick control product. Sensitivities may occur after using ANY pesticide product on dogs. Dogs may experience some temporary irritation at the site ofproduct application. Ifsigns ofsensitivity occur bathe your dog with a mild soap and rinse with large amounts ofwater. Ifsigns continue, consult a veterinarian immediateIiby calling 1-800-781-4738. [{Outer Packaging}] How to open: Remove producttubes [vial] from the package. Separate one tube from the others. Holding the tube [vial] with notched end pointing up and away from the face and body, cut off the narrow end at the notches with scissors.
How to apply: Inverttube over dog and use open end to part dog's hair. Squeeze tube finnly to apply all ofthe solution to the dog's skin, as directed below. Repeat application may be made if necessary, but do not apply more often than once every 30 days 4 weeks. [Optional drawings that mayormay not appear on finished label] FREQUENCY OF APPLICATION Use [brand name] monthly for complete control offlea, tick [and] chewing lice [and to kill mosquitoes] [infestations]. [£tudies show that] [brand name] kills fleas for up to three moR-ths. Ifyour pet is athigh risk for flea reinfestation [, or in a highly infested environment], apply Version I0.1 Page 5 of9 

# Sergeant's@ Master Label EPA Reg. No. 2517-RUR 10 March 2011 Information in [ ] is optional.
DIRECTIONS FOR USE It is a violation ofFederal law to use this product in a manner inconsistent with its labeling. DO NOT ALLOW CHILDREN TO APPLY PRODUCT. TO PREVENT HARM TO YOU AND YOUR DOG, READ ENTIRE LABEL BEFORE EACH USE. FOLLOW ALL DIRECTIONS AND PRECAUTIONARY STATEMENTS CAREFULL

### Y. FOR EXTERNAL USE ON DOGS ONLY. DO NOT USE ON RABBITS. DO NOT USE ON OTHER ANIMALS. DO NOT USE ON CATS. May be toxic and potentially fatal ifapplied to or ingested by cats. FOREXTERNAL USE ON DOGS ONLY. Do not use on puppies under 12 weeks ofage. Weigh your dog to be sure you are applying the right dose formulated for the weight ofyour dog. Do not treat your dog with more than one pesticide product at a time. Over dosing your dog can result in serious illness and even death. Best ifused year round. Certain medications can interact with pesticides. Consult a veterinarian before using this product on debilitated, aged, medicated, pregnant, or nursing dogs. Consult a veterinarian before using on dogs with known organ dysfunction. DO NOT USE ON CATS or animals other than dogs. Separate the treated dog from all other dogs and cats for 24 hours after treatmenthas been applied. Cats and dogs that actively groom orengage in close physical contactwith treated dog may be at risk ofserious harmful effects. The most common signs ofingestion are excessive salivation and foaming at the mouth. Ifthese symptoms occur immediately feed your dog and continue to monitor your dog for the next 24 hours. Ifsymptoms persist call 1-800-781-4738 to talk to a veterinarian. Cats exhibiting these same symptoms from ingestion should be taken to the veterinarian immediately. Ifyour dog is exhibiting signs ofand/or are being treated for skin dermatitis, talk to your vet before applying any topical flea and tick control product. Sensitivities may occur after using ANY pesticide product on dogs. Dogs may experience some temporary irritation at the site ofproduct application. Ifsigns ofsensitivity occur bathe your dog with a mild soap and rinse with large amounts ofwater. Ifsigns continue, consult a veterinarian immediateIiby calling 1-800-781-4738. [{Outer Packaging}] How to open: Remove producttubes [vial] from the package. Separate one tube from the others. Holding the tube [vial] with notched end pointing up and away from the face and body, cut off the narrow end at the notches with scissors.
How to apply: Inverttube over dog and use open end to part dog's hair. Squeeze tube firmly to apply all ofthe solution to the dog's skin, as directed below. Repeat application may be made if necessary, but do not apply more often than once every 30 days 4 weeks. [Optional drawings that mayor may not appear on finished label] FREQUENCY OF APPLICATION Use [brand name] monthly for complete control offlea, tick [and] chewing lice [and to kill mosquitoes] [infestations]. [£tudies show that] [brand name] kills fleas for up to three moR-ths. Ifyour pet is athigh risk for flea reinfestation [, or in a highly infested environment], apply

# Sergeant's® Master Label 10 March 201 

### I Version 10.1 EPA Reg. No. 25l7-RUR Information in [ ] is optional. Page 6 of9 monthly. Apply monthly to control ticks, mosquitoes and chewing lice. [Brand name] kills mosquitoes within 24 hours for up to the first 7 days aftertreatment, then within 48 hours for up to 

### 28 days. [Brand name] remains effective, even after bathing, water immersion, or exposure to 

### sunlight. Allow treated areato dry 

### thoroughly. Do not reapply for 30 days.
For Dogs Weighing up to 22 lbs. [including small dogs and puppies, 12 weeks or older] {For cartons containing .67 ml (0.023 fl. 

### oz.) applicator tubes} Apply one tube (.67 ml)(O.023 fl. 

### oz.) [as a spotto the dog's back between the shoulder blades] [from the back ofthe neckto a pointmidway between the neck and tail]. 

### For Dogs Weighing Between 23

- 441bs. {For cartons containing 

### 1.34 ml (0.045 

### fl. oz.) applicatortube} 

### [Apply one tube (1.34 ml)(0.045 fl. 

### oz.) as a spot to the dog's backbetween the shoulder blades.] [from the back ofthe neck to a point midway between the neck and tail].
For Dogs Weighing Between 45

- 881bs. 

### {For cartons containing 2,68 ml (0.091 fl. 

### oz.) applicator tube} Apply one tube (2.68 ml)(0.091 fl. 

### oz.) [as a spot on the dog's back betweenthe shoulder] [from the back ofthe neckto a point midway between the neck and tail]. 

### ForDogs Weighing 89 -132 lbs. {For cartons containing 4.02 ml (0.136 fl. oz.) applicator tube} 

### Apply one tube (4.02 ml)(0.136 fl. 

### oz.) [as a spot on the dog's backbetweenthe shoulder] [from the back ofthe neckto a point midway between the neck and tail]. 

### STORAGE AND 

### DISPOSAL PESTICIDE STORAGE: Do not remove tube from the packuntil ready to use. Store in a cool [below 77°F (2s'q] dryplace inaccessible to children and pets. Do not refrigerate. Protectfrom direct sunlight. 

### CONTAINERDISPOSAL 

### HANDLING: If

### empty: Non-refillable container. Do not reuse or refill this container. Offer for recycling ifavailable. 

### Ifpartly filled: Call your local solid waste agency for disposal instructions. Never place unused product down any indoor or outdoor drain. 

### [WARRANTY Read the entire Directions for Use and Warranty before usingthis Product. By using this product, user or buyer accepts the following warranty. HThe directions for use ofthis product are believed to adequate and mustbe followed carefully. It is impossible to eliminate all risks associated with the use ofthis product. Unintended consequences may result because ofunknown factors. All such risks shall be assumed by the user orbuyer.H Sergeant's is committedto providing high quality products. To the extentconsistentwith applicable law, Sergeant's makes no warranties, express orimplied, of merchantability or offitness for a particular purpose or otherwise, that extend beyond statements on this label. To the extent consistent with applicable law, Sergeant's, the manufacturer, orthe Seller shall not be liable for indirect, special, incidental or consequential damages. To the extentconsistentwith applicable law, the exclusive remedy ofthe user or buyer shall not exceed the purchase price paid.] [Ifyou have questions orcomments aboutthis product, please write: Sergeant's ConsumerResponse, 

### P.O. Box 

### 540399, Omaha, NE 68154-0399.] 

# Sergeant's@ Master Label 10 March 201 

### I Version 10.1 EPA Reg. No. 25l7-RUR Information in [ ] is optional. Page 6 of9 monthly. Apply monthly to control ticks, mosquitoes and chewing lice. [Brand name] kills mosquitoes within 24 hours for up to the first 7 days aftertreatment, then within 48 hours for up to 

### 28 days. [Brand name] remains effective, even after bathing, water immersion, or exposure to 

### sunlight. Allow treated areato dry 

### thoroughly. Do not reapply for 30 days.
For Dogs Weighing up to 22 lbs. [including small dogs and puppies, 12 weeks or older] {For cartons containing .67 ml (0.023 fl. 

### oz.) applicator tubes} Apply one tube (.67 ml)(O.023 fl. 

### oz.) [as a spotto the dog's back between the shoulder blades] [from the back ofthe neckto a pointmidway between the neck and tail]. 

### For Dogs Weighing Between 23

- 441bs. {For cartons containing 

### 1.34 ml (0.045 

### fl. oz.) applicatortube} 

### [Apply one tube (1.34 ml)(0.045 fl. 

### oz.) as a spot to the dog's backbetween the shoulder blades.] [from the back ofthe neck to a point midway between the neck and tail].
For Dogs Weighing Between 45

- 881bs. 

### {For cartons containing 2,68 ml (0.091 fl. 

### oz.) applicator tube} Apply one tube (2.68 ml)(0.091 fl. 

### oz.) [as a spot on the dog's back betweenthe shoulder] [from the back ofthe neckto a point midway between the neck and tail]. 

### ForDogs Weighing 89 -132 lbs. {For cartons containing 4.02 ml (0.136 fl. oz.) applicator tube} 

### Apply one tube (4.02 ml)(0.136 fl. 

### oz.) [as a spot on the dog's backbetweenthe shoulder] [from the back ofthe neckto a point midway between the neck and tail]. 

### STORAGE AND 

### DISPOSAL PESTICIDE STORAGE: Do not remove tube from the packuntil ready to use. Store in a cool [below 77°F (2s'q] dryplace inaccessible to children and pets. Do not refrigerate. Protectfrom direct sunlight. 

### CONTAINERDISPOSAL 

### HANDLING: If

### empty: Non-refillable container. Do not reuse or refill this container. Offer for recycling ifavailable. 

### Ifpartly filled: Call your local solid waste agency for disposal instructions. Never place unused product down any indoor or outdoor drain. 

### [WARRANTY Read the entire Directions for Use and Warranty before usingthis Product. By using this product, user or buyer accepts the following warranty. HThe directions for use ofthis product are believed to adequate and mustbe followed carefully. It is impossible to eliminate all risks associated with the use ofthis product. Unintended consequences may result because ofunknown factors. All such risks shall be assumed by the user orbuyer.H Sergeant's is committedto providing high quality products. To the extentconsistentwith applicable law, Sergeant's makes no warranties, express orimplied, of merchantability or offitness for a particular purpose or otherwise, that extend beyond statements on this label. To the extent consistent with applicable law, Sergeant's, the manufacturer, orthe Seller shall not be liable for indirect, special, incidental or consequential damages. To the extentconsistentwith applicable law, the exclusive remedy ofthe user or buyer shall not exceed the purchase price paid.] [Ifyou have questions orcomments aboutthis product, please write: Sergeant's ConsumerResponse, 

### P.O. Box 

### 540399, Omaha, NE 68154-0399.]

# Sergeant's@ MasterLabel 10 March2011 Version 10.1 EPA Reg. No. 2517-RUR 

### Infonnation in [ ] is optional. Page 7 of9 In Case ofEmergency, call: 1**~800~** 781**~4738** [For more infonnation] [Visit us at] [\vww.senreants.com] Non-Emergency call1-800-224-PETS (7387) [Made in USA] 

### Distributed by: Sergeant's Pet Care Products, Inc. P.O. Box 540399 Omaha, NE 68154-0399 EPA Reg. No. 2517-RUR EPA Est. No. XXXXX-XX-XXX [BAR CODE AREA]



### [How to Apply

- 

### May contain graphics illustrating product usc, e.g., dog with a drop falling onto its neckfrom a vial on front, side, or back carton label and/or applicator labeling.] [Application Instructions] [Directions for Use[ How to open 

### 1. Remove product tubes [vial] from the package. 2. Separate one tube from the others. Holding the tube [vial] with 

### notched end pointing up and away from the face and body, cut offthe narrow end atthe notches with 

### scissors. How to apply: 1. Inverttube over dog and use open end to part dog's hair. 2. Squeeze tube firmly to apply all ofthe solutionto the dog's skin [as a spotto the dog's back betweenthe shoulderblades.] [or] [from the back ofthe neckto a pointmidway between the neck and tail.]

[Flea life cycle diagram] [Flea Life Cycle] [Sample coloring and layout may be different on fin.II.bel)

[Look atthe Label (Look.tthe Label icon) 6 Step [Easy] [Spot On] [Squeeze-On] [Topical] Checklist

• Read the label completely and follow directions

• Weigh your pet

• Do NOT use Dog products on Cats

• Do NOT treat with more than one pesticide product at atime 

# Sergeant's® Master Label 10 March 2011 Version 10.l EPA Reg. No. 2517-RUR Infonnation in [ ] is optionaL Page 7 of9 In Case ofEmergency, call: 1-800-781-4738 [Formore information] [Visit us at] [\vww.senreants.com] Non-Emergency call 1-800-224-PETS (7387) [Made ill 

### USA] Distributed by: Sergeant's Pet Care Products, Inc. P.O. Box 540399 Omaha, NE 68154-0399 EPA Reg. No. 2517-RUR EPA Est. No. XXXXX-XX-XXX [BAR CODE AREA]

[How to Apply

- May contain graphics illustrating product use, e.g., dog with a drop falling onto its neckfrom a vial on front, side, or back carton label and/or applicator labeling.] [Application Instructions] [Directions for UseE How to open 

### 1. Remove product tubes 

### [vial] from the package. 2. Separate one tube from the others. Holding the tube 

### [vial] with notched end pointing up and away from the face and body, cut offthe narrow end atthe notches with scissors. How to apply: 

### 1. Inverttube over dog and use open end to part dog's hair. 2. Squeeze tube firmly to apply all ofthe solutionto the dog's skin [as a spotto the dog's back betweenthe shoulderblades.] [or] [from the back ofthe neckto a pointmidway between the neck and tail.]

[Flea life cycle diagram] [Flea Life Cycle] [Sample coloring and layout may be different on final label]

[Look atthe Label (Look atthe Label icon) 6 Step [Easy] [Spot On] [Squeeze-On] [Topical] Checklist

• Read the label completely and follow directions

• Weigh your pet

• Do NOT use Dog products on Cats

• Do NOT treat with more than one pesticide product at atime

# Sergeant's@ MasterLabel 10 March 201 I Version 10.1 EPA Reg. No. 25 17-RUR 

### Infonnation in [ ] is optional. Page 8 of9

• Separate animals aftertreatment to avoid chance ofingestion

• Do NOT split tubes between pets] 

### [Brand Namel [3] [Month [Treatment] [Application] Tracker] [Foryear-round protection, apply [Brand name] monthly.] [Pet's Name (Empty blank for ownerto fill in name)] [First] [1st] [Second] [2nd] [Third] [3rd] [Dose] [Treatment] [Application](Emptyblank for ownerto fill in date)(Date: MMlDD/YY)] 

### [calendar stickers with brand name] [Place stickers on your calendar as a reminder to reapply [brand name] [in 30 days.] [Monthly Application Reminder Magnet (image ofreminder magnet)] [Enclosed for your convenience is an application reminder magnet. Push the (reset) button, and the reminder lightwill blinktwice. The remindertag is now set for 30 days. Atthe end of30 days the reminderlight will blink, reminding you to reapply [Brand name]. Press the button once and the blinking lightwill stop. Press the button again and this will reset the timer for another 30 days.]



### flea eggs flea larvae 

## '" AduttFlea 

# @ AduttFlea 

# @ fleaeggs flea larvae flea pupae

# ~. flea pupae



## ,. ticks 

# @ ticks 

## Brown Dog

## lick 

# @ Brown Dog

## lick

DeerTick 

# @ Deerlick AmericanDoglick 

# @ AmericanDoglick 

# l' chewinglice 

# @ chewinglice LoneStarlick 

# @ LoneStarlick 

## .7J<- mosquitoes 

# .@c mosquitoes [Optional graphics above mayor may not appear on finished label] (END OPTIONAL INSERT OR PACKAGE COPY) 

# Sergeant's® Master Label 10 March 2011 Version 10.1 EPA Reg. No. 2517-RUR Infonnation in [ ] is optional. Page 8 of9

• Separate animals aftertreatmentto avoid chance ofingestion

• Do NOT 

### splittubes between pets] [Brand Name[ [3] [Month [Treatment] [Application] Tracker] [Foryear-round protection, apply [Brand name] monthly.] [Pet's Name (Empty blank for ownerto fill in name)] [First] [1st] [Second] [2nd] [Third] [3rd] [Dose] [Treatment] [Application](Emptyblank for ownerto fill in date)(Date: MMlDD/YY)] 

### [calendar stickers with brand name] [Place stickers on your calendar as a reminder to reapply [brand name] [in 30 days.] [Monthly Application Reminder Magnet (image ofreminder magnet)] [Enclosed for your convenience is an application reminder magnet. Pushthe (reset) button, and the reminder lightwill blinktwice. The remindertag is now set for 30 days. Atthe end of30 days the reminderlight will blink, reminding you to reapply [Brand name]. Press the button once and the blinking lightwill stop. Press the button again and this will reset the timer for another 30 days.] 

### AdultFlea 

# @ Adult Flea 

### .". flea eggs 

# @ flea eggs

., flea larvae flea larvae

.. flea pupae

# ~.. flea pupae 

# + ticks 

# @ ticks Brown DogTick 

# @ Brown Dog

### lick



## DeerTick 

# @ DeerTick American Dog Tick 

# @ American DogTick 

# Jr chewing lice 

# @ chewing lice lone

## Starlick 

# @ lone

## StarTick

mosquitoes

# -~ mosquitoes [Optional graphics above mayor may not appear on finished label] 

### (END OPTIONAL INSERT OR PACKi\CE COPY)

### 10 March 2011 Information in 

## I ]is optionaL 

# Sergeant's® Master Label Version 10.1 EPA Reg. No. 25l7-RUR Page90f9



### Front Label



# . . ... ········1 i l)OJI!oT 

### {Brand Name}

# i@~;:N For Dogs [ap 10 X lbs.] [X-Y lbs.] 

### Fiproni19.8% w/w, 

### Pyriproxyfen 2.0% **w/w** 

### Dog 0.023 fl 

### oz (or) 0.045 fl 

### 02 (or) 0.091 fl 

### 02 (or)0.136 fl 

### 02 l1abel code} BackLabel KEEP OUT OF REACH OF CHILDREN 

### WARNING: Read directions and precautions before using. Use scissors to open. 

### EPA REG. No. 2517-RUR {label code}



### MAB 2 3 10 March 2011 Information in 

## I ] is optionaL 

# Sergeant's® Master Label Version 10.1 EPA Reg. No. 2517-RUR Page90f9

Front Label ,·············,,··········,,····················1 

# i@l'XJJlloT

, U$l!ON 

### {Brand Name} 

### I CAn; 

### For Dogs [up to X lbs.]**[X~** 

### Y lbs.] Fiproni19.8% w/w, Pyriproxyfen 2.0% w/w Dog 0.023 fl 02 (or) 0.045 fl 02 (or) 0.091 fl 02 (or) 0.136 fl 02 {label code} Back Label KEEP OUT OF REACH OF CHILDREN WARNING: Read directions and precautions before using. Use scissors to open. EPA REG. No. 2517-RUR {label code}

# s60pJoJ. 

# X pueJ8

-

# ><

Brand 

# X m 

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38.tmm



# -- tOmm

ART INSTRUCTION FORTHE PRINTER 

# .l1li**6lAC~** IMS 16S**Pri"t~rf'lendor:** Mditicnol Notes: Dote**s~nt:**

labels adhere to White Tubes



### MAR ! 

### 3 Front WhitetubeIBlacktexton awhitelabelfColoredStrip

38.tmm 8mm



# ..--.-

tOmm

ART INSTRUCTION FORTHE PRINTER 

# •**6lAC~** IMS 16S Pri**"t~** r flendor: Mditicnol Notes: Dote**s~nt:**

labels adhere to White Tubes



### MAR 3

## ( \ 

# C'=J e-I 

## 'Y

l ) \ J J I I**----"--"--~-"'** I \ } \ I I I ::..•: ::: :.**~.,'"** I 

# 3.000 AppllCaUons 

## SENTRY. 

# Bran for

%!f6 '\::·J/.V ;;fiJi' KEEP OUTOF REACH OF CHILDREN 

### WARNING 

# ,.

chewing lice**o:,~(m()t;;nuitoes** Controls mites thatmay causesarcopticmange

• Waterproof

ACTIVE INGREDIENTS: Fjp,on;1 9.80%**Pl'fipro~ylen** 2.00% OTHER INGREDIENTS', ,88.20% TOTAL: ,.,.,.", "" 100.00% 'DiethyloneGlycol Monoelhyl Ether, Vitamin E Nlcollnate

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ACTIVE INGREDIENTS: Fipronjl •.•......................................•S.80%**Pl'fipro~ylen** 2.00% OTHER INGREDIENTS', , ,88.20% TOTAL: tOO.OO% 'Diethylone Glycol Monoethyl Ether, Vitam In E Nleolinate 

## i"i,

..**~'rnbsq** u

## itoes

# """'i"'~"Contro's mites thatmay causesarcopticmange

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# v777~7\ " 

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### WARNING 5<1!lla<kLahtiP"""IfurAdditionalPr.<a<Jtionl'Y511t.ments r-=,---------, 

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### (1.34 mL) applicatorsFront White lube/BlackleX! on awhile labelIColored Strip

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# .. Brond X for**Dog~** 23.JJ UsT-lobel ART INSTRUCTiON FORTHEPRINTER 

# •• Pnnter/Vendor: Additionol Notes: Dote**~ent:** 38.1mm amm



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10mm

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## 3 Front White lube/BlackleX! on awhile labelIColored Strip

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## ....--...-

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ART INSTRUCTiON FORTHEPRINTER 

# • Pnnter/Vendor: Additional Notes: Dote**~ent:**

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SENTRY.

## aIDof-~----- I

## I"--For~~ 

## ONl.:Y-**o~** dogs 'j) 

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## \II' 

## fleas

... flea eggs +ticks 

## 't chewing lice '?'mosquitoes

;:. Controlsmites thatmay causesarcopticmange

• Waterproof

ACTIYE INGREDIENTS, Fipronil , 9,80% P.,.ripro.yfen •..........•...•...•............2.00% OTHER INGREDIENTS':.. ..88.20% TOTAL, """",, 100.00% "Dl"1hylana Glycol Mon""thylEthar, Vitamin E Nlco1inata

TOF REACH OF CHILDREN 

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### NetContents: Three0.091 Iloz (2.68 mL)applicators 

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ACTIVE INGREDIENTS; Fi pronil , 9,80% P.,..iproxyfen •.•.........•...•...•............2.00% OTHER INGREDIENTS': 88.20% TOTAL; 100.00% '01,,1 hylana Glycol Mon""thylEthar, Vitaml n E N Ico1 inata

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### RNING 

### NetContents: Three0.091 fl oz (2.68 mL)applicatorsFront WhitetubefBlacktextonawhitelabelfColored Strip

38.tmm 8mm



# --

10mm

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# --

BlACK PMHOO Printer/Vendor: Additionol Notes: Dote sent:

labels adhere to White Tubes



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38.tmm 8mm



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# •

BlACK PMHOO Printer/Vendor: Additionol Notes: Dote sent:

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## '" fleas

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ACTIVE INGREDIENTS: Fipronil 9.80% PyriprOl<yten "

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TOF REACH OFCHILDREN 

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# ... Brand Xlor Dogs B9-132lBs T-lobel ARTINSTRUCTION FOR THE PR1NTER



# _.

BlACK**PM~294S** Printer/Vendar: Additional**Note~:** Dote**~cnt:** 38.tmm 8mm



## .--..

tQmm

Labels adhere to White Tubes



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# ... Brand Xlor Dogs B9-132lBs T-lobel ARTINSTRUCTION FOR THE PR1NTER 

# •

BlACK**PM~** 2945 Printer/Vendor: Addilian 0IN**ate~:** Dote**~cnt:** 38.tmm 8mm



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### MAR 2 3ARTlNSTRUCTlON FORTHE PRINTER 

# • BackTube Label

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38.1mm



## -.. 10mm

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KEEPOllTOfREACK OfCKILDREN

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# •

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Labels adhere to White Tubes



## 2-517-141 M.A.R 2 3ART INSTRUCTION FORTHE PRINTER 

# --

BlACK 1MS 173S Printer/Yendor: Additional Notel: Dote sent:



## 25'n-I,+1 MAR 23 ART INSTRUCTION FORTHE PRINTER 

# •

BlACK 1MS 173S Printer/Yendor: Additional Notel: Dote sent:



### MAR 2 3

### MAR 23

# r Q /Decision 

### #: 438358 DP 

### #: (382775) 

### PRIA Parent DP 

### #: Submission 

### #: 880181 

### DATA PACKAGE BEAN SHEET Date: 05-0ct-2010 Page t of2



### *

### * * Registration Information 

### * * * Registration:**~~JZ::BJlR.~.§_I;R.G_I;~_~·II'§**

### __**E!~BgJ~~_b** 

### __ __**~_Yb~~LS~l! EEZI;-ON** **~OR D_Q@~**  Company:**~~~!_:_~_~_~~_E!'-~!,_~.~E!** 

### __**~~_~.§_~R~~l.:!~~~_,_~~~:-** _ Risk Manager:**~M 1~-=---F3.~chard**  Gebken_:**(70~)12E:§!9LI3_?_i?~~_~y~** 

### __**~_~I_~~!** 

### ._ Risk Manager RevIewer: Rosanna Louie RLOUIE Sent Date: Calcula1ed Due Date: 23-Mar-2011 Edited Due Date: Type of Registration: Product**Re~~ratio~~_~!?~on** 

### L Action DesC".**LF3.~.!9L~'§YY ~_132!?_l!_~!l.l2_~:~~~T** **!~~_~** 

### __**~_~_~_Ll.:!g.§§** __**~_~~~~~~_q~E~_~uCI_~~_~~l~_**

Ingredients: 1291**~f~pr0.!:lll(9-.:..~L** _

_**12903~yriprt?.~!:!:'(2'Y"J** _ 

### * ** Data Package Information 

### * **
Expedite: 

### 0 Yes • No Date Sent: 05-0ct-20 fO Due Back:
DP Ingredient:**_~~~_~~~:_~y!~_~_T:_~**

## __ 129t2f, Fipronil DP Tille:**~~~!_!_~~_~~~_~r.?_?':19!** __**~_~_:_f!1_i':'~ry** __**~:~i:_~** _ CSF Included: • .Yes 

### 0 No Label Included: • Yes 

### 0 No Parent DP#:

Organization: RD fTRB Date In Date Out / Last Possible Science Due Date: 21-Feb-2011 (

-------------------- Team Name: CHEM

------------------------ Reviewer Name: 

## lJt.\JsJ

## tdlti~,.J:L~I;t**---.!?~~~t** Contractor Name: 

### ____O_3-!CXZ/20 {

## I Science Due Date: 

# .90;lzs-l-a Sub Data Package Due Date:



### * * * Studies Sent for Review 

### * * *
Printed on Page 2


### * * *Additional Data Package for this Decision 

### * * *
Can be printed on its own page


### ** * Data Package Instructions 

### ** *
Attn TRBfCHEM: Please conduct a product chemistry review the attached package in support of Ihe proposed product, containing fipronil and pyriproxyfen (nylar). Contact Rosanna Louie-Juzwiak at 308,0037 with any questions. Attachments:

- cover letter

• basic CSF

- draft label

- MRIDs 48189401, -02 Decision 

### #: 438358 DP 

### #: (382775) 

### PRIA Parent DP 

### #: Submission 

### #: 880181 

### DATA PACKAGE BEAN SHEET Date: 05-0ct-2010 Page t of2



### *

### * * Registration Information 

### * * * Registration:**~~JZ::BJlR.~.§_I;R.G_I;~_~·II'§**

### __**E!~BgJ~~_b** 

### __ __**~_Yb~~LS~l! EEZI;-ON** **~OR D_Q@~**  Company:**~~~!_:_~_~_~~_E!'-~!,_~.~E!** 

### __**~~_~.§_~R~~l.:!~~~_,_~~~:-** _ Risk Manager:**~M 1~-=---F3.~chard**  Gebken_:**(70~)12E:§!9LI3_?_i?~~_~y~** 

### __**~_~I_~~!** 

### ._ Risk Manager RevIewer: Rosanna Louie RLOUIE Sent Date: Calcula1ed Due Date: 23-Mar-2011 Edited Due Date: Type of Registration: Product**Re~~ratio~~_~!?~on** 

### L Action DesC".**LF3.~.!9L~'§YY ~_132!?_l!_~!l.l2_~:~~~T** **!~~_~** 

### __**~_~_~_Ll.:!g.§§** __**~_~~~~~~_q~E~_~uCI_~~_~~l~_**

Ingredients: 1291**~f~pr0.!:lll(9-.:..~L** _

_**12903~yriprt?.~!:!:'(2'Y"J** _ 

### * * * Data Package Information 

### * * *
Expedite: 

### 0 Yes • No Date Sent: 05-0ct-20 fO Due Back:
DP Ingredient:**_~~~_~~~:_~y!~_~_T:_~**

## __ 129t2f, Fipronil DP Tille:**~~~!_!_~~_~~~_~r.?_?':19!** __**~_~_:_f!1_i':'~ry** __**~:~i:_~** _ CSF Included: • .Yes 

### 0 No Label Included: • Yes 

### 0 No Parent DP#:

Organization: RD fTRB Date In Date Out / Last Possible Science Due Date: 21-Feb-2011 (

-------------------- Team Name: CHEM

------------------------ Reviewer Name: 

## lJt.\JsJ

## tdlti~,.J:L~I;t**---.!?~~~t** Contractor Name: 

### ____O_3-!CXZ/20 {

## I Science Due Date: 

# .90;lzs-l-a Sub Data Package Due Date:



### * * * Studies Sent for Review 

### * * *
Printed on Page 2


### * * *Additional Data Package for this Decision 

### * * *
Can be printed on its own page


### * * * Data Package Instructions 

### * * *
Attn TRBfCHEM: Please conduct a product chemistry review the attached package in support of Ihe proposed product, containing fipronil and pyriproxyfen (nylar). Contact Rosanna Louie-Juzwiak at 308,0037 with any questions. Attachments:

- cover letter

• basic CSF

- draft label

- MRIDs 48189401, -02DP#: (382775)

48189402

48189401

48189402

4818940t

48t89402

48189401

48189401

48189401

48189401

48t89402 Page 2 S1udles Sentfor Review"**~.,**

for Dogs. Project Number: 0/06. Unpublished study prepared by Sergeant's Pe1 Care Products, Inc. 6 p. Hoskins, K. (2010) Group B Product Chemistry for Sergeant's Fipronll + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/10/06. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 6 p. Hoskins, K. (2010) Group A Product Chemistry for Sergeant's Firponil + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/10/05. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 53 p. Hoskins, K. (2010) Group B Product Chemistry for Sergeant's Fipronil + Nylar Squeeze·On for Dogs. Project Number: SERGEANTS/07/1O/06. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 6 p. Hoskins, K. (2010) Group A Product Chemistry for Sergeant's Firponil + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/10/05. Unpublished study prepared by Sergeant's Pe1 Care Products, Inc. 53 p. Hoskins, K. (2010) Group B Product Chemistry for Sergeant's FipronH + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/10/06. Unpublished s1udy prepared by Sergeant's Pet Care Products, Inc. 6 p. Hoskins, K. (2010) Group A Product Chemistry for Sergeant's Firponil + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/10/05. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 53 p. Hoskins, K. (2010) Group A Product Chemistry for Sergeant's Firponil + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/10/05. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 53 p. Hoskins, K. (2010) Group A Product Chemistry for Sergeant's Firponil + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/10/05. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 53 p. Hoskins, K. (2010) Group A Product Chemistry for Sergeant's Firponil + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/1O/05. Unpublished study prepared by Sergeant's Pe1 Care Products, Inc. 53 p. Hoskins, K. (2010) Group B Product Chemistry for Sergeant's Fipronil + Nylar Squeeze-On for D09S. Project Number: SERGEANTs/07l1 0/06. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 6 p. Decision#: (438358)

830.7300IDensity/relative density

830.1670/Dlscussion offormation of impurities
830.6303/Physical slate

830.1550/Productldentity and composition

830.6302JColor

830.1620/Description of production process

830.1750/Certified limits

830.1600lDescription of materials used to produce the product
830.1650lDescription offormulation process

830.6304/0dor DP#: (382775)

48169402

48189402

48189401

48189402

4818940t

48t89402

48189401

48189401

48189401

48189401

48t89402 Page 2**~ ~ ~** S1udles Sentfor Review .,**~.,** Hoskins, K. (2010) Group B Product Chemistry for Sergeant's Fipronil + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07l1 0/06. Unpublished study prepared by Sergeant's Pe1 Care Products, Inc. 6 p. Hoskins, K. (2010) Group B Product Chemistry for Sergeant's Fipronll + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/10/06. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 6 p. Hoskins, K. (2010) Group A Product Chemistry for Sergeant's Firponil + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/10/05. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 53 p. Hoskins, K. (2010) Group B Product Chemistry for Sergeant's Fipronil + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/1O/06. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 6 p. Hoskins, K. (2010) Group A Product Chemistry for Sergeant's Firponil + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/10/05. Unpublished study prepared by Sergeant's Pe1 Care Products, Inc. 53 p. Hoskins, K. (2010) Group B Product Chemistry for Sergeant's FipronH + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/1 0106. Unpublished s1udy prepared by Sergeant's Pet Care Products, Inc. 6 p. Hoskins, K. (2010) Group A Product Chemistry for Sergeant's Firponil + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/10/05. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 53 p. Hoskins, K. (2010) Group A Product Chemistry for Sergeant's Firponil + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/10/05. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 53 p. Hoskins, K. (2010) Group A Product Chemistry for Sergeant's Firponil + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/10/05. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 53 p. Hoskins, K. (2010) Group A Product Chemistry for Sergeant's Firponil + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/1O/05. Unpublished study prepared by Sergeant's Pe1 Care Products, Inc. 53 p. Hoskins, K. (2010) Group B Product Chemistry for Sergeant's Fipronil + Nylar Squeeze-On for D09S. Project Number: SERGEANTs/07l1 0106. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 6 p. Decision#: (438358) 830-7100Niscosity

830.7300IDensity/relative density

830.1670/Dlscussion offormation of impurities
830.6303/Physical slate

830.1550/Productldentity and composition

830.6302lColor

830.16201Description of production process

830.1750/Certified limits

830.1600lDescription of materials used to produce the product
830.1650lDescription offormulation process

830.6304/0dorDP BAR CODE NO.: 382775 PC Codels): 129121, 129032 FOOD Use: No

DATE OUT: February 18, 2011 FILE SYMBOL NO.: 2517-RUR DECISION NO.: 438358 ACTION CODE: R310 NON-FOOD Use: Yes

SUBJECT; End Use Product Chemistry Review Product Name: Sergeant's Fipronil + Nylar Squeze-On for Dogs FROM:

TO: Hari Mukhoty, Product Chemistry Team Technical Review Branch I Registration Division (7505P) Rosanna Louie I Richard Gebken PM -10 Insecticide Branch I Registration Division (750SP)
Company Name: Formulation Type: INTRODUCTION: Sergeant's Pet Care Products, Inc. Liquid

The Registrant has re-submttted one basic CSF (dated: 02/28/2011), an amended CSF (dated: 02/2812011) to the aforesaid basic as an alternate formulation (Alt # 1) and a proposed product specific label (dated 08/11/2010) for registration ofthe aforesaid products under EPA File Symbol No. 2517-RUR. The registrant submitted product chemistry data under MRIDs: 481894-01 and -02 to support the registration of the proposed product.
The primary review ofthe product chemistry data was performed by a contractor (attached as the last page ofthis review) and TRB is conducting the secondary review. TRB has been requested to evaluate the product chemistry data required for the registration of the proposed basic product.
SUMMARY OF FINDINGS: 1. Name ofActive Ingredient(s): Fipronil (9.8%) and Pyriproxyfen (2.0%). 2. The source materials of the active ingredients are registered with the Agency. 3. All inert ingredients have been screened by IIAB on 02/2212011 and have found to be approved for nonfood uses only. DP BAR CODE NO.: 382775 PC Codels): 129121, 129032 FOOD Use: No

DATE OUT: February 18, 2011 FILE SYMBOL NO.: 2517-RUR DECISION NO.: 438358 ACTION CODE: R310 NON-FOOD Use: Yes

SUBJECT; End Use Product Chemistry Review Product Name: Sergeant's Fipronil + Nylar Squeze-On for Dogs FROM:

TO: Hari Mukhoty, Product Chemistry Team Technical Review Branch I Registration Division (7505P) Rosanna Louie I Richard Gebken PM -10 Insecticide Branch I Registration Division (750SP)
Company Name: Formulation Type: INTRODUCTION: Sergeant's Pet Care Products, Inc. Liquid

The Registrant has re-submttted one basic CSF (dated: 02/28/2011), an amended CSF (dated: 02/2812011) to the aforesaid basic as an alternate formulation (Alt # 1) and a proposed product specific label (dated 08/11/2010) for registration ofthe aforesaid products under EPA File Symbol No. 2517-RUR. The registrant submitted product chemistry data under MRIDs: 481894-01 and -02 to support the registration of the proposed product.
The primary review ofthe product chemistry data was performed by a contractor (attached as the last page ofthis review) and TRB is conducting the secondary review. TRB has been requested to evaluate the product chemistry data required for the registration of the proposed basic product.
SUMMARY OF FINDINGS: 1. Name ofActive Ingredient(s): Fipronil (9.8%) and Pyriproxyfen (2.0%). 2. The source materials of the active ingredients are registered with the Agency. 3. All inert ingredients have been screened by IIAB on 02/2212011 and have found to be approved for nonfood uses only.DP BAR CODE NO.: 382775 PC Code(s): 129121, 129032 FOOD Use: No 4. Confidential Statement of Formula(s): FILE SYMBOL NO.: 2517·RUR DECISION NO.: 438358 ACTION CODE: R310**NON~FOOD** Use: Yes

[XJ Basic- Dated: 0811112010 resubmitted

- Dated: 02/28/2011 [X) Alternate #

. Dated: 0212812011 Alternate CSF(s) complies with 40CFR §152.43: [X 

### JYes [[ No. 5. Product label

a. Ingredient statement Nominal concentration of AI listed on CSF(s) concur with product label (PR Notice 91-2) [X [Yes Metallic equivalent: [ 1Yes [X [NA; Soluble arsenic: [J Yes [ X [NA Isomeric ratios: [[ Yes [ X [ NA b. Health related sub statements: Petroleum distillate at > 10%: [J Yes [ 

### JNo [X 

### JNA Methanolat>4%: [ JYes 

## r [No [X [NA

c. Physical chemical hazard statement: Product label requires a statement per 40 CFR §156.78 for: flammability, explosive potential or electric insulator breakdown? [ X [Yes [[ No The label needs a flammability statement: Combustible. Do not use or store near heat or open flame. Is the sub statement in compliance with PR Notice 97-6? [X [YES

- Uses the term "Other Ingredients"

, if not, explain below: d. Label' requires an additional Storage and Disposal statement: [ [Yes [X [No

- from product chemistry point ofview; ifyes explain below: Final decision of overall label acceptance will be made by the PM.



### 2 DP BAR CODE NO.: 382775 PC Code(s): 129121, 129032 FOOD Use: No 4. Confidential Statement of Formula(s): FILE SYMBOL NO.: 2517·RUR DECISION NO.: 438358 ACTION CODE: R310**NON~FOOD** Use: Yes

[XJ Basic- Dated: 0811112010 resubmitted

- Dated: 02/28/2011 [X) Alternate # . Dated: 0212812011 Alternate CSF(s) complies with 40CFR §152.43: [X 

### JYes [[ No. 5. Product label

a. Ingredient statement Nominal concentration of AI listed on CSF(s) concur with product label (PR Notice 91-2) [X [Yes Metallic equivalent: [ 1Yes [X [NA; Soluble arsenic: [J Yes [ X [NA Isomeric ratios: [[ Yes [ X [ NA b. Health related sub statements: Petroleum distillate at > 10%: [J Yes [ 

### JNo [X 

### JNA Methanolat>4%: [ JYes 

## r [No [X [NA

c. Physical chemical hazard statement: Product label requires a statement per 40 CFR §156.78 for: flammability, explosive potential or electric insulator breakdown? [ X [Yes [[ No The label needs a flammability statement: Combustible. Do not use or store near heat or open flame. Is the sub statement in compliance with PR Notice 97-6? [X [YES

- Uses the term "Other Ingredients"

, if not, explain below: d. Label' requires an additional Storage and Disposal statement: [ [Yes [X [No

- from product chemistry point ofview; ifyes explain below: Final decision of overall label acceptance will be made by the PM.



### 2DP BAR CODE NO.: 382775 PC Code(s): 129121, 129032 FOOD Use: No 6. Group A: Product Chemistry Data FILE SYMBOL NO.: 2517-RUR DECISION NO.: 438358 ACTION CODE: R310**NON~FOOD** Use: Yes

TRB's determination ofthe acceptability of the data for the proposed product is listed in the tables below. Data submitted Guideline TRB's No. Study Title Assessment MRID Nos. of Data 481894-01 Yes No Product Identity & Composition A " 830.1550 X Description of materials used to A " 830.1600 

### oroducetheoroduct X Description offormulation X A " 830.1650 orocess Discussion on the formation of X " 830.1670 impurities A 830.1700 Preliminarv analvsis NA Standard certified Limits X A " Certified limits Proposed Limits (158.350) Justification for 830.1750 wider limits Enforcement analytical method Cited MRID: 481226-01 from A- GC using EPA Reg. No. 830.1800 X FID 2517-140

A

## = Acceptance, NA = NotAcceptable, G = Data Gap, W = Waiver Request, I = In Progress, NA

## =Not Applicable

3 DP BAR CODE NO.: 382775 PC Code(s): 129121, 129032 FOOD Use: No 6. Group A: Product Chemistry Data FILE SYMBOL NO.: 2517-RUR DECISION NO.: 438358 ACTION CODE: R310**NON~FOOD** Use: Yes

TRB's determination ofthe acceptability of the data for the proposed product is listed in the tables below. Data submitted Guideline TRB's No. Study Title Assessment MRID Nos. of Data 481894-01 Yes No Product Identity & Composition A " 830.1550 X Description of materials used to A " 830.1600 

### oroducetheoroduct X Description offormulation X A " 830.1650 orocess Discussion on the formation of X " 830.1670 impurities A 830.1700 Preliminarv analvsis NA Standard certified Limits X A " Certified limits Proposed Limits (158.350) Justification for 830.1750 wider limits Enforcement analytical method Cited MRID: 481226-01 from A- GC using EPA Reg. No. 830.1800 X FID 2517-140

A

## = Acceptance, NA = NotAcceptable, G = Data Gap, W = Waiver Request, I = In Progress, NA

## =Not Applicable

3DP BAR CODE NO.: 382775 PC Code(s): 129121, 129032 FOOD Use: No 7. Group B: FILE SYMBOL NO.: 2517-RUR DECISION NO.: 438358 ACTION CODE: R310 NONMFOOD Use: Yes

Guideline Study Title Value or Qualitative TRS's MRIDNos. No. Description Assessment 481894-02 of Data

" 830.6303 Physical State Liquid A " 830.6315 Flammabilitv Flash Point is > 194 Cl F A " No explosive material in the 830.6316 Explodability formulation NA " Not soluble/dispersible in 830.7000 pH water A " Density (Specific 830.7300 

### aravltv) 1.02M 1.06 qr/cc A "

A

## = Acceptance, N = Not Acceptable, G

## =Data Gap, W = Waiver request, NA

## =Not applicable, I = In progress

CONCLUSIONS:

1. TRS has reviewed the CSFs (dated: 02/28/2011) for the proposed basic and alternate (Alt. # 1) products and has found them to be acceptable. The CSFs are attached with this review in OPPIN CHEM DOCS. 2. Product chemistry Group A and Group B data, with the exception of one year storage stability (830.6317) and corrosion characteristics (830.6320) are satisfied and acceptable. 3. The registrant must generate one year storage stability (830.6317) and corrosion characteristics (830.6320) data on the proposed product. It is required that the observations be made at 0, 3, 6, 9, and 12 month intervals. The results must be submitted to the Agency in electronic and hard copy format. 4. The proposed label was screened as it pertains to the product chemistry requirements. The final review ofthe proposed label and uses are the purview ofthe PM team.

4 DP BAR CODE NO.: 382775 PC Code(s): 129121, 129032 FOOD Use: No 7. Group B: FILE SYMBOL NO.: 2517-RUR DECISION NO.: 438358 ACTION CODE: R310 NONMFOOD Use: Yes

Guideline Study Title Value or Qualitative TRS's MRIDNos. No. Description Assessment 481894-02 of Data

" 830.6303 Physical State Liquid A " 830.6315 Flammabilitv Flash Point is > 194 Cl F A " No explosive material in the 830.6316 Explodability formulation NA " Not soluble/dispersible in 830.7000 pH water A " Density (Specific 830.7300 

### aravltv) 1.02M 1.06 qr/cc A "

A

## = Acceptance, N = Not Acceptable, G

## =Data Gap, W = Waiver request, NA

## =Not applicable, I = In progress

CONCLUSIONS:

1. TRS has reviewed the CSFs (dated: 02/28/2011) for the proposed basic and alternate (Alt. # 1) products and has found them to be acceptable. The CSFs are attached with this review in OPPIN CHEM DOCS. 2. Product chemistry Group A and Group B data, with the exception of one year storage stability (830.6317) and corrosion characteristics (830.6320) are satisfied and acceptable. 3. The registrant must generate one year storage stability (830.6317) and corrosion characteristics (830.6320) data on the proposed product. It is required that the observations be made at 0, 3, 6, 9, and 12 month intervals. The results must be submitted to the Agency in electronic and hard copy format. 4. The proposed label was screened as it pertains to the product chemistry requirements. The final review ofthe proposed label and uses are the purview ofthe PM team.

4DATA EVALUATION RECORD FIPRONIL PYRIPROXIFEN (Sergeant's Fipronil 

### +Nylar Squeeze-On for Dogs) STUDY TYPES; ProductIdentity and Composition (OPPTS 830.1550) Description ofMaterials Used to Produce the Product (OPPTS 830.1600) Description ofProduction Process (830.1620) Discussion ofFormation ofImpurities (OPPTS 830.1670) Preliminary Analysis (OPPTS 830.1700) Certified Limits (OPPTS 830.1750) Enforcement Analytical Method (OPPTS 830.1800) Physical and Chemical Characteristics (OPPTS 830.6302-830.7950)
MRIDs 481894-01 and 481894-02 Prepared for 

### Registration Division Office ofPesticide Programs U.S. Environmental Protection Agency One Potomac Yard 2777 South Crystal Drive

Arlington, VA 22202 Prepared by Toxicology and Hazard Assessment Group Environmental Sciences Division

Oak Ridge National Laboratory Oak Ridge, TN 37831

Task OrderNo. 1-45

Primary Reviewer: Eric B. Lewis, M.S. Secondary Reviewers: Sylvia Milanez, Ph.D., D.A.B.T.

Robert H. Ross, M.S., Group Leader Quality Assurance: Kimberly G. Slusher, M.S.

Disclaimer Signature: Date: Signature: Date: Signature: Date: Signature: Date: 

# Ie 

# tb

# uJ\{ Ro.wJ JM 1 1 1011

This review may have been altered subsequentto the contractor's signatures above. Oak Ridge National Laboratory managed and operated by UT-Battelle, LLC.\ for the U.S. Department ofEnergy under Contract No. DE-ACOS-000R2272S. DATA EVALUATION RECORD FIPRONIL PYRIPROXIFEN (Sergeant's Fipronil 

### +Nylar Squeeze-On for Dogs) STUDY TYPES; Product Identity and Composition (OPPTS 830.1550) Description ofMaterials Used to Produce the Product (OPPTS 830.1600) Description ofProduction Process (830.1620) Discussion ofFormation ofImpurities (OPPTS 830.1670) Preliminary Analysis (OPPTS 830.1700) Certified Limits (OPPTS 830.1750) Enforcement Analytical Method (OPPTS 830.1800) Physical and Chemical Characteristics (OPPTS 830.6302-830.7950)
MRIDs 481894-01 and 481894-02 Prepared for Registration Division Office ofPesticide Programs U.S. Environmental Protection Agency One Potomac Yard 2777 South Crystal Drive

Arlington, VA 22202 Prepared by Toxicology and Hazard Assessment Group Environmental Sciences Division

Oak Ridge National Laboratory Oak Ridge, TN 37831

Task OrderNo. 1-45
Primary Reviewer: Eric B. Lewis, M.S. Secondary Reviewers: Sylvia Milanez, Ph.D., D.A.B.T.

Robert H. Ross, M.S., Group Leader Quality Assurance: Kimberly G. Slusher, M.S.

Disclaimer Signature: Date: Signature: Date: Signature: Date: Signature: Date: 

### 2011

# ~,~?r~'<7,/~A5J~'1,lJ-I;h,f/JiUjt JAN 

## 1 I 

## LOll

This review may have been altered subsequentto the contractor's signatures above. Oak Ridge National Laboratory managed and operated by UT-Battelle, LLC.\ for the U.S. Department ofEnergy under Contract No. DE-ACOS-000R2272S.

### DATA PACKAGE BEAN SHEET Date: 05-0ct-2010 Page 1 of2 Decision 

### #: 438358 DP 

### #: (382776) 

### PRIA Parent DP 

### #: Submission 

### #: 880181 

### * 

### * * Registration Information 

### * * * Registration:

## ~~7-~UR,-g~G~A!'lT'S Fll'llON-'-Lc+_f'l'(LA_R SqUEEZE:Qi'l£Q[l_D_OQ! 

# /Vs,,-0 r 

### 11 / Company 25t7-SERGEANTSPETCAREPRODUCTS,INC

_

### ~. 

# L.k r
Risk Manager

## ~_~**t~ ~c~~_rd_** **~~£~~~** -

## F~3)**30?:6~O** t Ri?9m#

## ':':r:~_**~:T?E________** \

## ~~ Risk Manager Reviewer Rosanna lOUie RlOUIE 

# y rJ'
Sen! Date: Calculated Due Date: 23-Mar-20 t t Edited Due Dale: Type of Registration: Product Registration

-**Seclion_~_** Action Desc:**\~~_!~t~§~~~2!?-~~!~~2_~_~~~_~_!_!~~_~J~~~~_~~~~_~§~~~_Q~_PRC2QlJ~!_g!i_~~!~**

Ingredients:**t29~fiproni~@~_%)** _



### * * 

### * Data Package Information 

### * * *
Expedite: 

### 0 Yes. No Date Sent: 05-0ct-2010 Due Back: DP Ingredient: 129032, Pyriproxyfen

DP Title:**~25 t2:~.!:!.~~~.£0~I.9.?~L~~¥_~~":'~t::~**  

### _ CSF Included: • Yes 

### 0 No label Included: • Yes 

## 0 No Parent DP #:

Organization: RD I TRB Date In Date Out**~/**

.................. -.-.-- last Possible Science Due Date:

## ~!:Fe~~~1J. _ Team Name: TOX Science Due Date: Reviewer Name: Contractor Name: Sub Data Package Due Date:

_



### * * * Studies Sent for Review 

### * * *
Printed on Page 2



### * * * Additional Data Package for this Decision 

### * * * Can be printed on its own page



### * * * Data Package Instructions 

### * * * Attn TRBfTOX: Please conduct an acute toxicity review ofthe attached package in support ofthe proposed product. Contact Rosanna louie-Juzwiak at 308.0037 with any questl(lns. Attachments:

• cover letter

- basic CSF

- drafllabel

• Data Matrix 

### DATA PACKAGE BEAN SHEET Date: 05-0ct-2010 Page 1 of2 Decision 

### #: 438358 DP 

### #: (382776) 

### PRIA Parent DP 

### #: Submission 

### #: 880181 

### * 

### * * Registration Information 

### * * * Registration:

## ~~7-~UR,-g~G~A!'lT'S Fll'llON-'-Lc+_f'l'(LA_R SqUEEZE:Qi'l£Q[l_D_OQ! 

# /Vs,,-0 r 

### 11 / Company 25t7-SERGEANTSPETCAREPRODUCTS,INC

_

### ~. 

# L.k r
Risk Manager

## ~_~**t~ ~c~~_rd_** **~~£~~~** -

## F~3)**30?:6~O** t Ri?9m#

## ':':r:~_**~:T?E________** \

## ~~ Risk Manager Reviewer Rosanna lOUie RlOUIE 

# y rJ'
Sen! Date: Calculated Due Date: 23-Mar-20 t t Edited Due Dale: Type of Registration: Product Registration

-**Seclion_~_** Action Desc:**\~~_!~t~§~~~2!?-~~!~~2_~_~~~_~_!_!~~_~J~~~~_~~~~_~§~~~_Q~_PRC2QlJ~!_g!i_~~!~**

Ingredients:**t29~fiproni~@~_%)** _



### * * 

### * Data Package Information 

### * * *
Expedite: 

### 0 Yes. No Date Sent: 05-0ct-2010 Due Back: DP Ingredient: 129032, Pyriproxyfen

DP Title:**~25 t2:~.!:!.~~~.£0~I.9.?~L~~¥_~~":'~t::~**  

### _ CSF Included: • Yes 

### 0 No label Included: • Yes 

## 0 No Parent DP #:

Organization: RD I TRB Date In Date Out**~/**

.................. -.-.-- last Possible Science Due Date:

## ~!:Fe~~~1J. _ Team Name: TOX Science Due Date: Reviewer Name: Contractor Name: Sub Data Package Due Date:

_



### * * * Studies Sent for Review 

### * * *
Printed on Page 2



### * * * Additional Data Package for this Decision 

### * * * Can be printed on its own page



### * * * Data Package Instructions 

### * * * Attn TRBfTOX: Please conduct an acute toxicity review ofthe attached package in support ofthe proposed product. Contact Rosanna louie-Juzwiak at 308.0037 with any questl(lns. Attachments:

• cover letter

- basic CSF

- drafllabel

• Data MatrixDP#: (382776) Page 2

••• Studies Sent for Review·· • Decision#: (438358)

48129604

48129603

48129608

48129606

48129607

48129604

48129605 Leoni, A. (2010) Acute Dermal Toxicity (LimitTest) with Dog Products (in Rats): Final Report. Project Number: 100138B. Unpublished study prepared by BSL Bioservice Scientific Laboratories Gmbh. 34 p. Leoni, A. (2010) Acute Oral Toxicity Up and Down Procedure with Dog Products (in Rats): Final Report. Project Number: 100137B. Unpublished study prepared by BSL Bioservice Scientific Laboratories Gmbh. 45 p. Stelter, D. (2010) Test for Sensitization (Guinea Pig Maximisallon Test) with Dog Products (in Guinea Pigs): Final Report. Project Number: t00141B. Unpublished study prepared by BSL Bioservice Scientific Laboratories Gmbh. 41 p. Ahuja, V. (20 to) Acute Eye Irritation/Corrosion with Dog Products (in Rabbits): Final Report. Project Number: 100140B. Unpublished study prepared by BSL Bioservice Scientific Laboratories Gmbh. 33 p. Ahuja, V. (20 to) Acute Dermal Irritation/Corrosion with Dog Products (in Rabbits): Final Report. Project Number: 100139B. Unpublished study prepared by BSL Bioservice Scientific Laboratories Gmbh. 29 p. Leoni, A. (2010) Acute Dermal Toxicity (LimitTest) with Dog Products {in Rats}: Final Report. Profect Number: 100138B. Unpublished study prepared by BSL Bioservice Scientific Laboratories Gmbh. 34 p. Hoskins, K. (2010) Waiver Request of Requirement for Further Testing forAcute Inhalation Toxicity for Following Sergeant's Products: Sergeant's Fipronil + Cyphenothrin Squeeze-On for Dogs, Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On for Dogs, Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs, Sergeant's Fipronil + Nylar Squeeze-On for Dogs, Sergeant's Fipronil + Etofenprox Spot-On for Cats, Sergeant's Fipronil + Etofenprox + Methoprene Spot-On for Cats, Sergeant's Fipronil + Etofenprox + Nylar Spot-On for Cats, Sergeant's Fipronil + Nylar Spot-On for Cats. Project Number: SERGEANTS/06/10/0S. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 6 p. 870.1000/Acute Toxicity testing-background

870.t100/Acute Oral Toxicity

870.2600/Skin sensitizallon

870.2400/Acute eye irritation

870.2500/Acute dermal irritation

870.1200/Acute dermal toxicity

870.1300/Acute inhalation toxicity DP#: (382776) Page 2

••• Studies Sent for Review·· • Decision#: (438358)

48129604

48129603

48129608

48129606

48129607

48129604

48129605 Leoni, A. (2010) Acute Dermal Toxicity (LimitTest) with Dog Products (in Rats): Final Report. Project Number: 100138B. Unpublished study prepared by BSL Bioservice Scientific Laboratories Gmbh. 34 p. Leoni, A. (2010) Acute Oral Toxicity Up and Down Procedure with Dog Products (in Rats): Final Report. Project Number: 100137B. Unpublished study prepared by BSL Bioservice Scientific Laboratories Gmbh. 45 p. Stelter, D. (2010) Test for Sensitization (Guinea Pig Maximisallon Test) with Dog Products (in Guinea Pigs): Final Report. Project Number: t00141B. Unpublished study prepared by BSL Bioservice Scientific Laboratories Gmbh. 41 p. Ahuja, V. (20 to) Acute Eye Irritation/Corrosion with Dog Products (in Rabbits): Final Report. Project Number: 100140B. Unpublished study prepared by BSL Bioservice Scientific Laboratories Gmbh. 33 p. Ahuja, V. (20 to) Acute Dermal Irritation/Corrosion with Dog Products (in Rabbits): Final Report. Project Number: 100139B. Unpublished study prepared by BSL Bioservice Scientific Laboratories Gmbh. 29 p. Leoni, A. (2010) Acute Dermal Toxicity (LimitTest) with Dog Products {in Rats}: Final Report. Profect Number: 100138B. Unpublished study prepared by BSL Bioservice Scientific Laboratories Gmbh. 34 p. Hoskins, K. (2010) Waiver Request of Requirement for Further Testing forAcute Inhalation Toxicity for Following Sergeant's Products: Sergeant's Fipronil + Cyphenothrin Squeeze-On for Dogs, Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On for Dogs, Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs, Sergeant's Fipronil + Nylar Squeeze-On for Dogs, Sergeant's Fipronil + Etofenprox Spot-On for Cats, Sergeant's Fipronil + Etofenprox + Methoprene Spot-On for Cats, Sergeant's Fipronil + Etofenprox + Nylar Spot-On for Cats, Sergeant's Fipronil + Nylar Spot-On for Cats. Project Number: SERGEANTS/06/10/0S. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 6 p. 870.1000/Acute Toxicity testing-background

870.t100/Acute Oral Toxicity

870.2600/Skin sensitizallon

870.2400/Acute eye irritation

870.2500/Acute dermal irritation

870.1200/Acute dermal toxicity

870.1300/Acute inhalation toxicityDecision 

### #: 438358 DP 

### #: (382777) 

### PRIA Parent DP#: Submission 

### #: 880181 

### DATA PACKAGE BEAN SHEET Date: 05-0ct-2010 Page 1 of2



### * * * Registration Information 

### * * 

### * Registration:**~~tT:R!Jlt::,,§,~g@!;ANT§J:-'ERQ_NIL _~_~J'bAR** **~qU~EZE:9_~"--E9J~J)g@,~** Company: 2517

- SERGEANTS PET CARE PRODUCTS, INC, Risk Manager: RM to

- Richard Gebken

- (703)**~95~Q)** __**!39_<:'f.T.l.~_'=X!_§_~!~~?** 

### _ Risk Manager Reviewer: Rosanna Louie RLDUJE Sent Dale: Calculated Due Date: 23-Mar-2011 Edited Due Dale: Type of Registration:**~roduct** Registration

- Section 3 _ Action Desc:**(R310L~_~~** __**P._~2~~~_~~~2~~~_~_~_!** 

### __**~~~_~_I~CL_~Q~§_~~~~~_~_2f_f'ROOUCT ~_~~~JS~** 

Ingredients:**~291~!~.Yipronilt~,~~)** _



### * * * Data Package Information 

### * 

### * *
Expedite: 

### 0 Yes. No Date Sent: 05-0ct-2010 Due Back: DP Ingredient:**!3_~.0_~~~_~t~P~c.T=-~** N

_ 129121, Fipronil

CSF Included: • Yes 

### 0 No Label Included: • Yes 

### 0 No Parent DP #:

Organization:**_~L!:R~** __..
_ Team Name: TOX Date In Date Out /

Last Possible Science Due Date: 21-Feb-2011 ,/ Science Due Date: Reviewer Name: Sub Data Package Due Date: Contractor Name:



### * * * Studies Sent for Review 

### * * *
Printed on Page 2



### * 

### * * Additional Data Package for this Decision 

### * * * Can be printed on its own page


### * * * Data Package Instructions 

### * * * Attn TRBrrOX: Please conduct a companion animal safety study review of the attached package in support ofthe proposed product. Contact Rosanna Louie-Juzwiak at 308.0037 with any questions. Attachments:

- cover letter

- draft label

- data matrix



### -c...Sv: Decision 

### #: 438358 DP 

### #: (382777) 

### PRIA Parent DP#: Submission 

### #: 880181 

### DATA PACKAGE BEAN SHEET Date: 05-0ct-2010 Page 1 of2



### * * * Registration Information 

### * * 

### * Registration:**~~tT:R!Jlt::,,§,~g@!;ANT§J:-'ERQ_NIL _~_~J'bAR** **~qU~EZE:9_~"--E9J~J)g@,~** Company: 2517

- SERGEANTS PET CARE PRODUCTS, INC, Risk Manager: RM to

- Richard Gebken

- (703)**~95~Q)** __**!39_<:'f.T.l.~_'=X!_§_~!~~?** 

### _ Risk Manager Reviewer: Rosanna Louie RLDUJE Sent Dale: Calculated Due Date: 23-Mar-2011 Edited Due Dale: Type of Registration:**~roduct** Registration

- Section 3 _ Action Desc:**(R310L~_~~** __**P._~2~~~_~~~2~~~_~_~_!** 

### __**~~~_~_I~CL_~Q~§_~~~~~_~_2f_f'ROOUCT ~_~~~JS~** 

Ingredients:**~291~!~.Yipronilt~,~~)** _



### * * * Data Package Information 

### * 

### * *
Expedite: 

### 0 Yes. No Date Sent: 05-0ct-2010 Due Back: DP Ingredient:**!3_~.0_~~~_~t~P~c.T=-~** N

_ 129121, Fipronil

CSF Included: • Yes 

### 0 No Label Included: • Yes 

### 0 No Parent DP #:

Organization:**_~L!:R~** __..
_ Team Name: TOX Date In Date Out /

Last Possible Science Due Date: 21-Feb-2011 ,/ Science Due Date: Reviewer Name: Sub Data Package Due Date: Contractor Name:



### * * * Studies Sent for Review 

### * * *
Printed on Page 2



### * 

### * * Additional Data Package for this Decision 

### * * * Can be printed on its own page


### * * * Data Package Instructions 

### * * * Attn TRBrrOX: Please conduct a companion animal safety study review of the attached package in support ofthe proposed product. Contact Rosanna Louie-Juzwiak at 308.0037 with any questions. Attachments:

- cover letter

- draft label

- data matrix



### -c...Sv:DP#: (382777)

43121111

43121110

46166108

43863802

47849609

43577711

48129614

43121111

43444905

43121110

43863802 Page 2

* * * Studies Sent for Review * * * Decision#: (438358)

## ~~ E.

## ~=~~;;;( Topical Spray"(F Project Number: 94423: PS-232DAS. Unpublished study prepared by White Eagle Toxicology Labs. 171 p. Arnaud, J.; Consalvi, P. (1993) DomesticAnimal Safety: Assessment ofthe Tolerance of a 0.25% RM 1601 Spray in Nursing Puppies Administered Twice at a 28 Day IntelVal at a Dose Rate of6 mllkg: Revised: Lab Project Number CLI 180. Unpublished study prepared by Rhone Merieux, Inc. 32 p. Arnaud, J.; Consalvl, P. (1993) Assessment ofTolerance of a 0.25% RM 1601 Spray Formulation in Dogs at 3, 9, and 15 mllkg When Applied 6 times to the Haircoat at 28 Day IntelVals: Revised: Lab Project Number CLl138. Unpublished study prepared by Rhone Merieux, Inc. 69 p. Kuhn, J. (2003) Companion Animal Safety Study in Dogs: Cyphenothrin-IGR Spot-on for Dogs: Final Report. Project Number; 7650/03. Unpublished study prepared by Stillmeadow, Inc. and Miller, Thomas A. 53 p. Powell, L.; Paffett, R. (1995) Domestic Animal Safety Study by Topical Administration to Dogs: Fipronil Spo1 Treatment (RM 1601E): Lab Project Number: MRX 23/950406. Unpublished study prepared by Hunlingdon Research Centre, Ltd. 219 p. Delport, P. (2009) Companion Animal Safely Evaluation on Dogs of Spot-On Products Containing Multiple Toxicants and Insect Growth Regulators: Final Report. Project Number: 2517FEGEN, CV/08/551. Unpublished study prepared by Clin Vet International. 129 p. Walker, K. (1995) Discussion in Support of Bridging Domestic Animal Safety Data on Frontline Spray Treatment to Frontline SpotTreatment Data Package. Unpublished study prepared by Rhone Merieux, Inc. 6 p. Hoskins, K. (2010) Companion Animal Safety for Sergeanl's 870.7200/Companion animal safety Fipronil + Cyphenothrin Squeeze-On for Dogs. Project Number: SERGEANTS/06/10106. Unpublished study prepared by Sergeanl's Pet Care Products, Inc. 39 p. Amaud, J.; Consalvi, P. (1993) DomesUcAnimal Safety: 870.7200/Companion animal safety Assessment ofthe Tolerance of a 0.25% RM 1601 Spray in Nursing Puppies Administered Twice at a 28 Day IntelVal at a Dose Rate of6 ml/kg: Revised: Lab Project Number CLl180. Unpublished study prepared by Rhone Merieux, Inc. 32 p. Schwartz, E. (1994) DomesticAnimal Safety Study of RM1601C 870.7200/Companion animal safety Topical Spray (Frontline Spray Treatment) in Juvenile Dogs: Lab Project Number: 94423: PS-232DAS. Unpublished study prepared by White Eagle Toxicology Labs. 171 p. Arnaud, J.; Consalvi, P. (1993) Assessment of Tolerance ofa 870.7200/Companion animal safety 0.25% RM 1601 Spray Formulation in Dogs at 3, 9, and 15 mllkg When Applied 6 times to the Haircoat at28 Day IntelVals: Revised: Lab Project Number CLl138. Unpublished study prepared by Rhone Merieux, Inc. 69 p. Powell, L.; Paffett, R. (t995) DomesticAnimal Safety Study by 870.7200/Companion animal safety Topical Administration to Dogs: Fipronil Spot Treatment (RM t601 E): Lab Project Number: MRX 23/950406. Unpublished study prepared by Huntingdon Research Centre, Ltd. 219 p. DP#: (382777)

43121111

43121110

46166108

43863802

47849609

43577711

48129614

43121111

43444905

43121110

43863802 Page 2

* * * Studies Sent for Review * * * Decision#: (438358)

## ~~ E.

## ~=~~;;;( Topical Spray"(F Project Number: 94423: PS-232DAS. Unpublished study prepared by White Eagle Toxicology Labs. 171 p. Arnaud, J.; Consalvi, P. (1993) DomesticAnimal Safety: Assessment ofthe Tolerance of a 0.25% RM 1601 Spray in Nursing Puppies Administered Twice at a 28 Day IntelVal at a Dose Rate of6 mllkg: Revised: Lab Project Number CLI 180. Unpublished study prepared by Rhone Merieux, Inc. 32 p. Arnaud, J.; Consalvl, P. (1993) Assessment ofTolerance of a 0.25% RM 1601 Spray Formulation in Dogs at 3, 9, and 15 mllkg When Applied 6 times to the Haircoat at 28 Day IntelVals: Revised: Lab Project Number CLl138. Unpublished study prepared by Rhone Merieux, Inc. 69 p. Kuhn, J. (2003) Companion Animal Safety Study in Dogs: Cyphenothrin-IGR Spot-on for Dogs: Final Report. Project Number; 7650/03. Unpublished study prepared by Stillmeadow, Inc. and Miller, Thomas A. 53 p. Powell, L.; Paffett, R. (1995) Domestic Animal Safety Study by Topical Administration to Dogs: Fipronil Spo1 Treatment (RM 1601E): Lab Project Number: MRX 23/950406. Unpublished study prepared by Hunlingdon Research Centre, Ltd. 219 p. Delport, P. (2009) Companion Animal Safely Evaluation on Dogs of Spot-On Products Containing Multiple Toxicants and Insect Growth Regulators: Final Report. Project Number: 2517FEGEN, CV/08/551. Unpublished study prepared by Clin Vet International. 129 p. Walker, K. (1995) Discussion in Support of Bridging Domestic Animal Safety Data on Frontline Spray Treatment to Frontline SpotTreatment Data Package. Unpublished study prepared by Rhone Merieux, Inc. 6 p. Hoskins, K. (2010) Companion Animal Safety for Sergeanl's 870.7200/Companion animal safety Fipronil + Cyphenothrin Squeeze-On for Dogs. Project Number: SERGEANTS/06/10106. Unpublished study prepared by Sergeanl's Pet Care Products, Inc. 39 p. Amaud, J.; Consalvi, P. (1993) DomesUcAnimal Safety: 870.7200/Companion animal safety Assessment ofthe Tolerance of a 0.25% RM 1601 Spray in Nursing Puppies Administered Twice at a 28 Day IntelVal at a Dose Rate of6 ml/kg: Revised: Lab Project Number CLl180. Unpublished study prepared by Rhone Merieux, Inc. 32 p. Schwartz, E. (1994) DomesticAnimal Safety Study of RM1601C 870.7200/Companion animal safety Topical Spray (Frontline Spray Treatment) in Juvenile Dogs: Lab Project Number: 94423: PS-232DAS. Unpublished study prepared by White Eagle Toxicology Labs. 171 p. Arnaud, J.; Consalvi, P. (1993) Assessment of Tolerance ofa 870.7200/Companion animal safety 0.25% RM 1601 Spray Formulation in Dogs at 3, 9, and 15 mllkg When Applied 6 times to the Haircoat at28 Day IntelVals: Revised: Lab Project Number CLl138. Unpublished study prepared by Rhone Merieux, Inc. 69 p. Powell, L.; Paffett, R. (t995) DomesticAnimal Safety Study by 870.7200/Companion animal safety Topical Administration to Dogs: Fipronil Spot Treatment (RM t601 E): Lab Project Number: MRX 23/950406. Unpublished study prepared by Huntingdon Research Centre, Ltd. 219 p.UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION
February IS, 2011 MEMORANDUM Subject: Name ofPesticide Product:
EPA Reg. No. IFile Symbol: DP Barcodes: Decision No.: 

### Action Code: PC Codes: SERGEANT'S FlPRONIL 

### +NYLAR SQUEEZEON FORDOGS 2517-RUR DP 382776, 382777 438358 R310 129121 (Fipronil: 9.8%) 129032 (Pyriproxyfen: 2.0%)
From:



### To:

Registrant: Byron T. Backus, Ph.D., Toxicologist Technical Review Branch Registration Division (7S05P)
Rosanna Loiue-JuzwiakJRichard Gebken RM 10 Insecticide Branch Registration Division (7505P) SERGEANT'S PET CARE PRODUCTS, INC. FORMULATION FROM LABEL: 

### Active lngredient(s): 129121 Fipronil 129032 Pyriproxyfen Other lngredient(s): TOTAL

ACTION REQUESTED: The Risk Managerrequests: 

### bvwt. 9.8% 

### 2.0% 88.2% 100.0%

For DP 382776: "

...Please conduct an acute toxicity review ofthe attached package in support of the proposed product.

.. "

Page I of4 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION


### February 15,2011 MEMORANDUM Subject:

From:

To:

Registrant: Name ofPesticide Product: SERGEANT'S FlPRONIL 

### +NYLAR**SQUEEZE~** 

### ON FORDOGS EPA Reg. No. IFile Symbol: 2517-RUR DP Barcodes: DP 382776, 382777 Decision No.: 438358 Action Code: R310 PC Codes: 129121 (Fipronil: 9.8%) 129032 (Pyriproxyfen: 2.0%) Byron T. Backus, Ph.D., Toxicologist Technical Review Branch Registration Division (7505P) Rosanna Loiue-JuzwiaklRichard Gebken RM 10 Insecticide Branch Registration Division (7505P) SERGEANT'S PET CARE PRODUCTS, INC. FORMULATION FROM LABEL: Active Ingredient(s): 129121 Fipronil 129032 Pyriproxyfen Other Ingredient(s): TOTAL

ACTION REQUESTED: The Risk Managerrequests: bvwt. 9.8% 2.0% 88.2% 100.0%

For DP 382776: "

...Please conduct an acute toxicity 

### review ofthe attached package in support of the proposed product

.. "

Page I of4

### For DP 382777: "

...Please conduct a companion animal safety study review ofthe attached package in support ofthe proposed product.

.. " BACKGROUND: The material received for review includes a data matrix, a CSF (dated 8/11/2010) and a proposed label for this product, indicating use on adult dogs and puppies 12 weeks ofage and older. COMMENTS AND RECOMMENDATIONS: 1. The five cited acute toxicity studies (48129603, 48129604, 48129606

- 48129608) were conducted on a formulation containing as active ingredients: Fipronil (9.8%), (S)-Methoprene (8.5%), Cyphenothrin (5.5%) and Pyriproxyfen (2%). The studies were previously classified as acceptable (TRB memorandwn dated November 23, 2010 for**2517-~RUN),** 

### and can be used to support the registration of2517-RUR. The signal word is WARNING, based on the eye irritation potential (MRlD 48129606). 2. The material in the inhalation waiverrequest inMRlD 48129605 is applicable to**2517~RUR.** 

### Refer to the TRB memorandum dated November 23,2010 for**2517~RUN** 

### which states: "Based on the arnOlmt offormulation applied (0.5-4.5 mL), the packaging ofthese products**(single~use** 

### containers or ampoules), the non-volatile nature ofthe formulations, and the application method (directly to the skin ofthe dog or cat) which does not result in any respirable particles, TRB concludes that a waiver for the acute inhalation study requirement is appropriate, and thatthese products can be assigned to EPA Toxicity Category IV by this exposure route." 3. The proposed label dosage rates for 2517-RUR are 0.67 mL for dogs up to 221bs; 1.34 mL for dogs 23-441bs; 2.68 mL for dogs 45-881bs; and 4.02 mL for dogs 89-1321bs. The cited companion animal safety studies include l\1RID 47849609, in which six Group A2 puppies were treated with 5 applications ofsubstance lA (containing 8.2% cyphenothrin and 9.8% fipronil) and 5 applications ofsubstance II (55.16% etofenprox, 8.78% methoprene and 2.31 % pyriproxyfen). The mean total dose was 1.84 (range: 1.79-1.88) mLlkg for test substance IA and 6.88 (range: 6.69-7.05) mLlkg for substance 11. Group B2 adults were treated with 5 applications ofsubstance IA and 5 applications ofsubstance TIl (8.90% methoprene, 2.43% pyriproxyfen). The mean total dose was 0.395 (range: 0.352-0.443) mLlkg for substance fA and 0.395 (range: 0.352-0.443) mLlkg for substance III. Asswning thatthe test substances and proposed product have a specifiC gravity = 

### 1.0, the puppies were treated with means of 180 mg fipronil/kg, and 159 mg pyriproxyfen/kg. Dividing these values by 5 would give 36 mg fipronil/kg and 31.8 mg pyriproxyfen/kg. In terms ofthe formulation for**25l7~RUR** 

### these values would be 0.367, and 1.59 mLlkg, respectively, indicating that 0.67 mL would be acceptable for puppies weighing 1.83 (0.67 mL divided by 0.367 mLlkg) kg or more. 1.83 kg is 4.03 1b, so (applying a 5X safety factor) we can acceptthe data for dogs weighing 4 pounds ormore. The cited companion animal safety studies adequately supportthe use ofthis product on dogs and puppies 12 weeks old or older. Labeling should indicate a minimum weight of4 lbs for dogs or puppies.

Page 2 of4 

### For DP 382777: "

...Please conduct a companion animal safety study review ofthe attached package in support ofthe proposed product.

.. " BACKGROUND: The material received for review includes a data matrix, a CSF (dated 8/11/2010) and a proposed label for this product, indicating use on adult dogs and puppies 12 weeks ofage and older. COMMENTS AND RECOMMENDATIONS: 1. The five cited acute toxicity studies (48129603, 48129604, 48129606

- 48129608) were conducted on a formulation containing as active ingredients: Fipronil (9.8%), (S)-Methoprene (8.5%), Cyphenothrin (5.5%) and Pyriproxyfen (2%). The studies were previously classified as acceptable (TRB memorandwn dated November 23, 2010 for**2517-~RUN),** 

### and can be used to support the registration of2517-RUR. The signal word is WARNING, based on the eye irritation potential (MRlD 48129606). 2. The material in the inhalation waiverrequest inMRlD 48129605 is applicable to**2517~RUR.** 

### Refer to the TRB memorandum dated November 23,2010 for**2517~RUN** 

### which states: "Based on the arnOlmt offormulation applied (0.5-4.5 mL), the packaging ofthese products**(single~use** 

### containers or ampoules), the non-volatile nature ofthe formulations, and the application method (directly to the skin ofthe dog or cat) which does not result in any respirable particles, TRB concludes that a waiver for the acute inhalation study requirement is appropriate, and thatthese products can be assigned to EPA Toxicity Category IV by this exposure route." 3. The proposed label dosage rates for 2517-RUR are 0.67 mL for dogs up to 221bs; 1.34 mL for dogs 23-441bs; 2.68 mL for dogs 45-881bs; and 4.02 mL for dogs 89-1321bs. The cited companion animal safety studies include l\1RID 47849609, in which six Group A2 puppies were treated with 5 applications ofsubstance lA (containing 8.2% cyphenothrin and 9.8% fipronil) and 5 applications ofsubstance II (55.16% etofenprox, 8.78% methoprene and 2.31 % pyriproxyfen). The mean total dose was 1.84 (range: 1.79-1.88) mLlkg for test substance IA and 6.88 (range: 6.69-7.05) mLlkg for substance 11. Group B2 adults were treated with 5 applications ofsubstance IA and 5 applications ofsubstance TIl (8.90% methoprene, 2.43% pyriproxyfen). The mean total dose was 0.395 (range: 0.352-0.443) mLlkg for substance fA and 0.395 (range: 0.352-0.443) mLlkg for substance III. Asswning thatthe test substances and proposed product have a specifiC gravity = 

### 1.0, the puppies were treated with means of 180 mg fipronil/kg, and 159 mg pyriproxyfen/kg. Dividing these values by 5 would give 36 mg fipronil/kg and 31.8 mg pyriproxyfen/kg. In terms ofthe formulation for**25l7~RUR** 

### these values would be 0.367, and 1.59 mLlkg, respectively, indicating that 0.67 mL would be acceptable for puppies weighing 1.83 (0.67 mL divided by 0.367 mLlkg) kg or more. 1.83 kg is 4.03 1b, so (applying a 5X safety factor) we can acceptthe data for dogs weighing 4 pounds ormore. The cited companion animal safety studies adequately supportthe use ofthis product on dogs and puppies 12 weeks old or older. Labeling should indicate a minimum weight of4 lbs for dogs or puppies.

Page 2 of44. The following is the acute toxicity profile for Sergeant's Fipronil 

### + Nylar Squeeze-On for Dogs (EPA File Symbol 2517-RUR), based on the results ofthe acute toxicity studies:
Acute oral toxicity Acute dennal toxicity Acute inhalation toxicity Primary eye irritation Primary dermal irritation Dennal sensitization 

### III III (IV) II IV Positive Cited Cited Waived Cited Cited Cited MRID 48129603 MRID 

### 48129604 (MRID 

### 48129605) MRID 

### 48129606 MRID 48I

### 29607 MRID 48129608
5. Based on the acute toxicity profile above, and taking into consideration the proposed uses specified on the label and information in the CSF, the following would be the precautionary and first aid labeling for EPA File Syrnbol25 17-RUR [Sergeant's Fipronil 

### +Nylar Squeeze-On for Dogs] as obtained from the Label Review System; PROOUCT 10 #: PRODUCT NAME: 002517-00141 SERGEANT'S FIPRONIL 

### + NYLAR SQUEEZE-ON FOR DOGS PRECAUTIONARY STATEMENTS SIGNAL WORO: WARNING Hazards to Humans and Domestic Animals: Restricted Use Pesticide due to toxicity categories. For retail sale to and use only by Certified Applicators or persons under their direct supervision and only for those uses covered by the Certified Applicator's certification. Child Resistant Packaging Required.

causes substantial but temporary eye injury. Harmful ifabsorbed through skin. Harmful ifswallowed. Do not get in eyes or on clothing. Wear protective eyewear (goggles, face shield, or safety glasses). Wash thoroughly with soap and water after handling and before eating, drinking, cheWing gum, or using tobacco. Remove and wash contaminated clothing before reuse. Avoid contact with skin. Wear**long~** sleeved shirt and long pants, socks, shoes, and gloves. Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals. First Aid: Ifin eyes:**~Hold** eye open and rinse slowly and gently with water for 15-20 minutes.**~Remove** contact lenses, if present, after the first 5 minutes, then continue rinsing. -Call a poison control center or doctor for treatment advice. Ifon skin: -Take offcontaminated clothing. -Rinse skin immediately with plenty ofwater for 15·20 minutes. -call a poison control center or doctor for treatment advice. Ifswallowed: -call a poison control center or doctor immediately for treatment advice. -Have person sip a glass ofwater ifable to swallow. -Do not induce vomiting unless told to by a poison control center or doctor. Page 3 of4 4. The following is the acute toxicity profile for Sergeant's Fipronil 

### + Nylar Squeeze-On for Dogs (EPA File Symbol 2517-RUR), based on the results ofthe acute toxicity studies:
Acute oral toxicity Acute dennal toxicity Acute inhalation toxicity Primary eye irritation Primary dermal irritation Dennal sensitization 

### III III (IV) II IV Positive Cited Cited Waived Cited Cited Cited MRID 48129603 MRID 

### 48129604 (MRID 

### 48129605) MRID 

### 48129606 MRID 48I

### 29607 MRID 48129608
5. Based on the acute toxicity profile above, and taking into consideration the proposed uses specified on the label and information in the CSF, the following would be the precautionary and first aid labeling for EPA File Syrnbol25 17-RUR [Sergeant's Fipronil 

### +Nylar Squeeze-On for Dogs] as obtained from the Label Review System; PROOUCT 10 #: PRODUCT NAME: 002517-00141 SERGEANT'S FIPRONIL 

### + NYLAR SQUEEZE-ON FOR DOGS PRECAUTIONARY STATEMENTS SIGNAL WORO: WARNING Hazards to Humans and Domestic Animals: Restricted Use Pesticide due to toxicity categories. For retail sale to and use only by Certified Applicators or persons under their direct supervision and only for those uses covered by the Certified Applicator's certification. Child Resistant Packaging Required.

causes substantial but temporary eye injury. Harmful ifabsorbed through skin. Harmful ifswallowed. Do not get in eyes or on clothing. Wear protective eyewear (goggles, face shield, or safety glasses). Wash thoroughly with soap and water after handling and before eating, drinking, cheWing gum, or using tobacco. Remove and wash contaminated clothing before reuse. Avoid contact with skin. Wear**long~** sleeved shirt and long pants, socks, shoes, and gloves. Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals. First Aid: Ifin eyes:**~Hold** eye open and rinse slowly and gently with water for 15-20 minutes.**~Remove** contact lenses, if present, after the first 5 minutes, then continue rinsing. -Call a poison control center or doctor for treatment advice. Ifon skin: -Take offcontaminated clothing. -Rinse skin immediately with plenty ofwater for 15·20 minutes. -call a poison control center or doctor for treatment advice. Ifswallowed: -call a poison control center or doctor immediately for treatment advice. -Have person sip a glass ofwater ifable to swallow. -Do not induce vomiting unless told to by a poison control center or doctor. Page 3 of4**~Do** not give anything to an unconscious person. NOTE TO PHYSICIAN: Note to PM(CRM(Registrant: The proposed label should contain a "Note to Physician". The following statements are suggested types ofinformation that may be included, if applicable:

- technical information on symptomatology;

- use ofsupportive treatments 

### to maintain life functions;

- medicine that will counteract the specific physiological effects ofthe pesticide; company telephone number to specific medical personnel who can provide specialized medical advice. Have the product container or label with you when calling a poison control center or doctor or going for treatment. You may also contact 1-800-xxx-xxxx for emergency medical treatment information, According to the LRS, this product is a candidate for restricted use because it is in Toxicity Category II for eye exposure. However, TRB concludes that, based on the packaging (in ampules) and proposed product use (direct application to the skin ofdogs or cats), the risk ofeye exposure is adequately reduced, and a restricted use classification is not necessary. 

### 6. The CSF (dated 8/1112010) for 2517-RUR should also be reviewed and accepted by the TRB Chemistry Team.

Page 4 of4**~Do** not give anything to an unconscious person. NOTE TO PHYSICIAN: Note to PMfCRMfRegistrant: The proposed label should contain a "Note to Physician". The following statements are suggested types ofinformation that may be included, if applicable:

- technical information on symptomatology;

- use ofsupportive treatments 

### to maintain life functions;

- medicine that will counteract the specific physiological effects ofthe pesticide; company telephone number to specific medical personnel who can provide specialized medical advice. Have the product container or label with you when calling a poison control center or doctor or going for treatment. You may also contact 1-800-xxx-xxxx for emergency medical treatment information, According to the LRS, this product is a candidate for restricted use because it is in Toxicity Category II for eye exposure. However, TRB concludes that, based on the packaging (in ampules) and proposed product use (direct application to the skin ofdogs or cats), the risk ofeye exposure is adequately reduced, and a restricted use classification is not necessary. 

### 6. The CSF (dated 8/1112010) for 2517-RUR should also be reviewed and accepted by the TRB Chemistry Team.

Page 4 of4Decision 

### #: 438358 DP 

### #: (382778) PRIA Parent DP #: Submission 

### #: 880181 

### '* '* '* Registration Information 

### '* '* '* 

### DATA PACKAGE BEAN SHEET Date: 05-0ct M2010 Page t ot 2 

## l't I Registration: 2517 M RUR
M**§ERG~l~.T~£I~B,Q~!"** __**!_~~f(hARJ?g~~~zEMON** FOR**DO~§** Company: 2517

- SERGEANTS PET CARE PRODUCTS, INC. Risk Manager:**~~_!9_':_~S:~_<l.~?_Qt::!?~t::~_E:~~L~_5-6Z2!B_oom.!_~,!!_~.:?~~?**

### _ Risk Manager Reviewer: Rosanna Louie RLOUIE Sent Date: Calculated Due Dale: 23-Mar-20t1 Edited Due Date:

Action Desc:**LI3_~_~QL~~~_~_'3_Q~~~~~~~N-FAST T~f~j~~LUQES** **_REV~~~_~QE:£RQQ~£r~_r:tE~~?_l**

Ingredients:**g_~t2t. FipronJl~.:.-8_~**  _



### '* '* '* Data Package Information 

### '* '* '* Expedile: 

### 0 Yes. No Date Sent: 05-0ct-20tO Due Back:
DP Ingredient:**!3_~_?_~3,_!:'_'t':~~~~_:~**

### __

_**t_?_~_!?~_,**

### __**,=_i~E~~~** _ DP Title: #2517-RUR: CRP Review CSF Included: • Yes 

## 0 No Label Included: • Yes 

### 0 No Parent DP #:

Organization: RD I TRB Date In 

# 0757/0

... ...••...••.............. Date Out

---------------



# r,l2:3\/.o last Possible Science Due Date: 2t-Feb-20t 1 Science Due Date: Reviewer Name: Sub Dala Package Due Date: Contractor Name:



### * * * Studies Sent for Review 

### * * *
Printed on Page 2



### * * * Additional Data Package for this Decision 

### * * 'I< Can be printed on its own page

'I< 'I< 'I< 

### Data Package Instructions 'I< 'I< 'I< Attn TRBlCRP: Please conduct a CRP Packaging review ofthe attached package in support ofthe proposed product. Contact Rosanna louie-Juzwiak at 308.0037 with any questions. Attachments:

- cover letter

- letterfor CRP certification (including cited studies)

- letlerfor CRP intormation

- basic CSF

- draft label

- data matrix

NOTE: with regards to CRP review, there is no greater toxicity from pyriproxyfen exposure (i.e., does nottrigger need for CRP) that would exceed Ihat ot fipronil. Decision 

### #: 438358 DP 

### #: (382778) PRIA Parent DP #: Submission 

### #: 880181 

### '* '* '* Registration Information 

### '* '* '* 

### DATA PACKAGE BEAN SHEET Date: 05-0ct M2010 Page t ot 2 

## l't I Registration: 2517 M RUR
M**§ERG~l~.T~£I~B,Q~!"** __**!_~~f(hARJ?g~~~zEMON** FOR**DO~§** Company: 2517

- SERGEANTS PET CARE PRODUCTS, INC. Risk Manager:**~~_!9_':_~S:~_<l.~?_Qt::!?~t::~_E:~~L~_5-6Z2!B_oom.!_~,!!_~.:?~~?**

### _ Risk Manager Reviewer: Rosanna Louie RLOUIE Sent Date: Calculated Due Dale: 23-Mar-20t1 Edited Due Date:

Action Desc:**LI3_~_~QL~~~_~_'3_Q~~~~~~~N-FAST T~f~j~~LUQES** **_REV~~~_~QE:£RQQ~£r~_r:tE~~?_l**

Ingredients:**g_~t2t. FipronJl~.:.-8_~**  _



### '* '* '* Data Package Information 

### '* '* '* Expedile: 

### 0 Yes. No Date Sent: 05-0ct-20tO Due Back:
DP Ingredient:**!3_~_?_~3,_!:'_'t':~~~~_:~**

### __

_**t_?_~_!?~_,**

### __**,=_i~E~~~** _ DP Title: #2517-RUR: CRP Review CSF Included: • Yes 

## 0 No Label Included: • Yes 

### 0 No Parent DP #:

Organization: RD I TRB Date In 

# 0757/0

... ...••...••.............. Date Out

---------------



# r,l2:3\/.o last Possible Science Due Date: 2t-Feb-20t 1 Science Due Date: Reviewer Name: Sub Dala Package Due Date: Contractor Name:



### * * * Studies Sent for Review 

### * * *
Printed on Page 2



### * * * Additional Data Package for this Decision 

### * * 'I< Can be printed on its own page

'I< 'I< 'I< 

### Data Package Instructions 'I< 'I< 'I< Attn TRBlCRP: Please conduct a CRP Packaging review ofthe attached package in support ofthe proposed product. Contact Rosanna louie-Juzwiak at 308.0037 with any questions. Attachments:

- cover letter

- letterfor CRP certification (including cited studies)

- letlerfor CRP intormation

- basic CSF

- draft label

- data matrix

NOTE: with regards to CRP review, there is no greater toxicity from pyriproxyfen exposure (i.e., does nottrigger need for CRP) that would exceed Ihat ot fipronil.DP#: (382778)

48059804

48059806

48059805 Page 2
*** Studies Sent for Review ***

### D09~""~ Applicator with label Indicator F=1 as a Poison Prevention Package**f~;S';g'''-'.':'.** Pet Care Products, Inc.: Final Report. Project Number: 1746f002. Unpublished study prepared by Perritt laboratories, Inc. 28 p. Ward, R. (20 to) Evaluation ofthe Dog Squeeze on 1.34ml White Applicatorwith Green label Indicator (3x), Scissors to Open

- F'" t as a Poison Prevention Package for Sergeant's Pet Care Products, Inc.: Final Report. Project Number: 1746f003. Unpublished study prepared by Perritllaboratories, Inc. 28 p. Ward, R. (20tO) Evaluation ofthe Dog Squeeze on 4.02ml White Applicatorwith Blue label Indicator (3x), Scissors to Open

- F::::1 as a Poison Prevention Package for Sergeant's Pet Care Products, Inc.: Final Report. Project Number: 1746f005. Unpublished study prepared by Perritllaboratories, Inc. 28 p. Ward, R. (20 to) Evaluation ofthe Dog Squeeze on 2.68ml White Applicatorwith Red label Indicator (3x), Scissors to Open

- F=1 as a Poison Prevention Package for Sergeant's Pet Care Products. Inc.: Final Report. Project Number: t746f004. Unpublished study prepared by Perritllaboratories, Inc. 28 p. Decision#: (438358) DP#: (382778)

48059804

48059806

48059805 Page 2
* * * Studies Sent for Review * * *

### D09~""~ Applicator with label Indicator F=1 as a Poison Prevention Package**f~;S';g'''-'.':'.** Pet Care Products, Inc.: Final Report. Project Number: 1746f002. Unpublished study prepared by Perritt laboratories, Inc. 28 p. Ward, R. (20 to) Evaluation ofthe Dog Squeeze on 1.34ml White Applicatorwith Green label Indicator (3x), Scissors to Open

- F'" t as a Poison Prevention Package for Sergeant's Pet Care Products, Inc.: Final Report. Project Number: 1746f003. Unpublished study prepared by Perritllaboratories, Inc. 28 p. Ward, R. (20tO) Evaluation ofthe Dog Squeeze on 4.02ml White Applicatorwith Blue label Indicator (3x), Scissors to Open

- F::::1 as a Poison Prevention Package for Sergeant's Pet Care Products, Inc.: Final Report. Project Number: 1746f005. Unpublished study prepared by Perritllaboratories, Inc. 28 p. Ward, R. (20 to) Evaluation ofthe Dog Squeeze on 2.68ml White Applicatorwith Red label Indicator (3x), Scissors to Open

- F=1 as a Poison Prevention Package for Sergeant's Pet Care Products. Inc.: Final Report. Project Number: t746f004. Unpublished study prepared by Perritllaboratories, Inc. 28 p. Decision#: (438358)UNITED STATES ENVIRONMENTALPROTECTiON AGENCY WASHINGTON, D.C. 2H-I6U

OFF!{'E OF C1JnnC.\L S,\.FETY .\1'0 POLI.(TTlOl' 1'IHXENT!ON 

### December23, 2010 NOTE TO RM 10 Rosanna Louie-Juzwiak SUBJECT: Certification to Compliance with Chiid-Resistant Packaging Reguiations EPA FILE NO: 2517-RUR, DP 382778, Decision 

### # 438358 The August 11, 2010 eRP certification and bridging lelter (indicating the same size and color package as package tested) for EPA Registration No. 2517-RUR are acceptabie. The August 11,2010 label for EPA Registration No. 2517-RUR has the same CRP directions as were used in the CRP testing, All the requirements for CRP have been met for EPA Registration No. 2517- RUR. The directions on opening the package given to consumers must be identical to those given to the seniors during testing. 

### Shouid any human experience/epidemiological evidence indicate a problem once the product is in the marketplace, the Agency reserves the right to reexamine this data comprehensively and to question the child resistance ofthe package involved. Thank you for your cooperation in this malter. Ifyou have any questions please contact me at (703)-308-7368.

Rosalind 

### L. Gross UNITED STATES ENVIRONMENTALPROTECTiON AGENCY WASHINGTON, D.C. 2H-I6U

OFF!{'E OF C1JnnC.\L S,\.FETY .\1'0 POLI.(TTlOl' 1'IHXENT!ON 

### December23, 2010 NOTE TO RM 10 Rosanna Louie-Juzwiak SUBJECT: Certification to Compliance with Chiid-Resistant Packaging Reguiations EPA FILE NO: 2517-RUR, DP 382778, Decision 

### # 438358 The August 11, 2010 eRP certification and bridging lelter (indicating the same size and color package as package tested) for EPA Registration No. 2517-RUR are acceptabie. The August 11,2010 label for EPA Registration No. 2517-RUR has the same CRP directions as were used in the CRP testing, All the requirements for CRP have been met for EPA Registration No. 2517- RUR. The directions on opening the package given to consumers must be identical to those given to the seniors during testing. 

### Shouid any human experience/epidemiological evidence indicate a problem once the product is in the marketplace, the Agency reserves the right to reexamine this data comprehensively and to question the child resistance ofthe package involved. Thank you for your cooperation in this malter. Ifyou have any questions please contact me at (703)-308-7368.

Rosalind 

### L. GrossSergeant's Pet Care Products, Inc. 2625 South 158ttl Plaza • Omaha, NE 68130·1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com



### August 11, 2010 Richard Gebken, PMI0 Office ofPesticide Programs (7504P) 

# u.s. Environmental ProtectionAgency DocumentProcessingDesk Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlinglon, VA 22202 Subject: 

### Child Resistant Packaging Certification Sergeant's Fipronil 

### +**N?",~<!!** 

### .§.gPeeze-On for Dogs EPAFile Symbol 25I7-)\lBW 

### {-(\.tit...
DearMr. Gebken; 

# !Zvl\ Sergeant's Fiprorril 

### +Nylar Squeeze-On for Dogs (EPA File**Symbo12517~** 

# • I certify thatthe packaging used forthe following product meets the standards of40 CFR 157.32, including the revised standards in 16 CFR 1700.15(b), when testedbythe revised testing procedures in 16 CFR 1700.20, as publishedin 60 FR 37710 (Jn1y 21, 1995);

Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 158th 

### Plaza, Omaha, NE 68130-1770, 

### EPA CompanyNumber 2517) is submittingthis child resistantpackaging certification to support for the new endwuse product Sergeant's Fipronil 

### + Nylar Squeeze-On for Dogs (EPAFile Symbol 25I7-NEW). All productlabels have language specifying the use ofscissors to open the 

### product container and label language 

### statingtheproduct is notto be applied bychildren. If

### you have any questions, please contact me at402w 938w7079. Sincerely,

Kelly R. Hoskins Manager ofTechnical Affairs



### cc: 

### LarryNouvel Sergeant's PetCare Products, Inc.

2625 South 158ttl Plaza • Omaha, NE 68130·1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com



### August 11,2010 Richard Gebken, PM1 0 Office ofPesticide Programs (7504P) 

# u.s. Environmental ProtectionAgency DocumentProcessing Desk Room SA900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202 Subject: Child Resistant Packaging Certification Sergeant's Fipronil 

### +**N?",~<!!** 

### .§.gPeeze-On for Dogs EPA File Symbol 2517w 

### pEW 

### (2...iJ..

## K



# fZvf\

• Sergeant's Fipronil 

### +Nylar Squeeze-On for Dogs (EPA File**Symbo12517~** 

### DearMr. Gebken:
I certify thatthe packaging used forthe following product meets the standards of40 CFR 157.32, including the revised standards in 16 CFR 1700.15(b), when testedbythe revised testing procedures in 16 CFR 1700.20, as publishedin 60 FR 37710 (July 21, 1995):

Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 158th 

### Plaza, Omaha, NE 68130 w 

### 1770, EPA CompanyNumber 251 7) is submitting this childresistantpackaging certification to support for the new endwuse product Sergeant's Fipronil 

### + Nylar Squeeze-On for Dogs (EPA File Symbol 2517w NEW). All productlabels have language specifying the use ofscissors to open the product containerand label language stating theproduct is notto be appliedby children. If

### you have any questions, please contactme at402w 938w7079. Sincerely,

Kelly R. Hoskins Manager ofTechnical Affairs

cc: Larry NouvelSergeant's 

### PetCare Products, Inc. 2625 South 158th Plaza • Omaha, NE**68130~1770** • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com


### August II, 2010 Rosalind Gross c/o Richard Gebken Registration Division Office ofPesticide Programs (7504P) U.S. Environmental ProtectionAgency DocumentProcessing Desk Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202 Subject: ChildResistant Packaging Infonnation**Ser~t's** 

### Fipronil 

### +Nylar Squeeze-On for Dogs (EPA File Symbol: 2517- 

## pmw) (.2\,l(l.. 

### DearMs. Gross: Sergeant's Pet Care Products, Inc. (Sergeants, 2625 South 158'" Plaza, Omaha, NE 68130-1770, EPA Company Number

### 2517) is submitting a requestto rely onpreviously submittedChild ResistantPackaging (CRP) studies to support this new registration. The CRP data were submitted to EPA on April 

### 12, 2010 in 

### support ofthe pending registration applications under EPA File Symbols: 25I7-RGT, 25I7-RGA, 2517-RGL, and 2517-RGU (all ofwhich contain Fipronil at 9.7-9.8%). Sergeant's generated CRP data on a standard white applicatorin sizes 

### 0.67, 1.34,2.68, and

### 4.02 mL. The following is a summary table ofthe applicators that were tested and submittedto EPA in the CRP data:
Use 

### AnnlicatorBase Color Fill Wei2htlmL) 

### Color DogUp to 22 Ibs White 0.67 Orange ,/ D0223-441bs White 1.34 Green \ /- Dog 45-88 lbs "White 2.68 Red V Doa 89-132 Ibs White 4.02 Blue 

### V CRP data is required for this new productbecause ofthe inclusion ofthe activf' ingredient fipronil (9.8%) in thepet squeeze-onproduct. The CRP testing was conducted. or1 a standard package size and color configurationthat is identical for this product. The**Ser3~3'1~'** 

### s Fip:-o;:il Nylar Squeeze-On for Dogs productbeing submittedtoday also contains fiproni: at 9.8% Additionally, Sergeant's alreadyhas dog squeeze-onproducts approvedby EPA ccntaining 2% Nylar (EPA Registration Numbers 2517-127 through 2517-129) that are not ,,'h!ectto CRP. This new product contains 2% nylar.

I Sergeant's PetCare Products, Inc. 2625 South 158th Plaza • Omaha, NE**68130~1770** • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com


### August 11,2010 Rosalind Gross c/o Richard Gebken Registration Division Office ofPesticide Programs (7504P) U.S. Environmental ProtectionAgency DocumentProcessing Desk Room**S~4900,** 

### One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202 Subject: ChildResistant Packaging Information**~_~~t's** 

### Fipronil 

### +Nylar Squeeze-On for Dogs (EPA File Symbol:**2517~** 

### p.rEW)

# rVAl. DearMs. Gross: Sergeant's Pet Care Products, Inc. (Sergeants, 2625 South 158th 

### Plaza, Omaha, NE 68130-1770, EPA Company Number2517) is submitting a requestto rely onpreviously submittedChild ResistantPackaging (CRP) studies to support this new registration. The CRP data were submitted to EPA on April 12, 2010 in 

### support ofthe pending registration applications under EPAFile Symbols: 2517-RGT, 2517-RGA, 2517-RGL, and 2517-RGU (all ofwhich contain Fipronil at**9.7~9.8%).** 

### Sergeant's generated CRP data on a standardwhite applicatorin sizes 0.67, 1.34,2.68, and4.02 mL. The following is a summary table ofthe applicators thatwere tested and submittedto EPA in the CRP data:
Use ApplicatorBase Color Fill Weight (mL) Color DogUp to 22 Ibs White 0.67 Orange 

## / Dog 23-44 Ibs White 1.34 Green \/. Dog 45-88 Ibs "White 2.68 Red 

### V, Dog 89-132 Ibs White 4.02 Blue 

# -:L
CRP data is required for this new productbecause ofthe inclusion ofthe activf' ingredient fipronil (9.8%) in thepet squeeze-onproduct. The CRP testing was conducted. or1 a standard package size and color configurationthat is identical for this product. The**Ser3~3'1~'** 

### s Fip:-o;:il .:- Nylar Squeeze-On for Dogs productbeing submittedtoday also contains fiproni: at 9.8% Additionally, Sergeant's alreadyhas dog squeeze-onproducts approvedby EPA ccntaining 2% Nylar (EPA Registration Numbers 2517-127 through 2517-129) that are not sllhiectto CRP. This new product contains 2% ny1ar.

1Sergeant's PetCare Products, Inc. 2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www,sergeants.CQm 

### Furthennore, Sergeant's does not anticipate any additional toxicitythrough the combination of fipronil and nylar. \Vhen Sergeant's Fipronil 

### +Nylar Squeeze-On for Dogs is marketed, itwill utilize the same applicator color (white) and fill weight colors permL fill weight as waS used in the submitted and referenced CRP testing. Basedon available infonnation, the density range of the pending products on which the CRP data were generated is the same as the new product (1.0- 1.5 gr/cc). 

### Therefore, Sergeant's is relying onMRlD's: 480591jll3, 48059804, 4805Z§lJ5, and 48059806 to fulfill the CRP datarequirements for Sergeant's'Fipronil 

### +Nylar Squeeze-On for Dogs. 

### V Ifyou have any questions, please contact me at402-938-7079. Sincerely,

Kelly R. Hoskins ManagerofTechnical Affairs

cc: LarryNouvel



### 2 Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www,sergeants.CQm 

### Furthennore, Sergeant's does not anticipate any additional toxicitythrough the combination of fipronil and nylar. \Vhen Sergeant's Fipronil 

### +Nylar Squeeze-On for Dogs is marketed, itwill utilize the same applicator color (white) and fill weight colors permL fill weight as waS used in the submitted and referenced CRP testing. Basedon available information, the density range of the pending products on which the CRP data were generated is the same as the new product (1.0- I.S gr/cc). 

### Therefore, Sergeant's is relying onMRID's:**480S~~3,** 

### 480S9804, 

### 480SZ§.OS, and 480S9806 to fulfill the CRP datarequirements for Sergeant's'Fipronil 

### +**~Iar** Squeeze-On for Dogs. 

### V 

### Ifyou have any questions, please contact me at402-938-7079. Sincerely,

# UJl~ 

# ?-

-**tk~lu-~ 1J2~T**  Kelly R. Hoskins ManagerofTechnical Affairs

cc: LarryNouvel



### 2Decision #: 438358 DP 

### #: (382779) PRIA Parent DP#: Submission #: 880181 

### DATA PACKAGE BEAN SHEET Date: 05-0ct-2010 Page t of2



### * * * Registration Information 

### * * * Registration:**~~1!::~Ylt:.~~~~GJ;~~NI:~J:H~BQ_~_'-~_~J~fLLA~t~'-QUEEZE -ON**  FOR DO_G§ Company:**?~** 17**_-_~~~§~!i!~-!:ET ~~~~~~Q~~~!S,_!NC.**  _ Risk Manager: RM)O

- Richard Gebken

- (703)**3~-.:-~~9_1_!3.<:I<:I~~_f_'(]** __**§.:?:.~~_~~** 

### _ Risk Manager Reviewer: Rosanna Louie RlOUIE Senl Date: Calculated Due Date: 23-Mar-2011 Edited Due Date:

Action Desc: (R310) NEW**PRODUC~~ON-YAS"I Tf¥.C!5j!ti~~~Q~_!3.~Y.~~~_2~_~~.2g9g_!_~!:!~_~~~_,** 

Ingredients: 

### ! 291**~:!.cXipr~~J!@~~~** 

### _



### * * * Data Package Information 

### * * * Expedite: 

### 0 Yes. No Dale Sen!: 05-0ct-2010 Due Back: OP Ingredienl: 129032, Pyriproxyfen**!?~~~!~£i~~_~il** 

### ._. _ DPTitle:**~_~!!_:RU_f3___=_~!!!.~_~9:'.~~Je~** _ CSF Included: 

### 0 Yes. No Label Included: • Yes 

### 0 No Parenl DP #:

Date In Date Out Last Possible Science Due Date: 21-Feb-2011 Team Name: Efficacy (IS) Science Due Date: Reviewer Name: Sub Data Package Due Dale:

_ Contractor Name:



### * * * Studies Sent for Review 

### * * *
Printed on Page 2



### * ** Additional Data Package for this Decision 

### * * * Can be printed on its own page


### * * * Data Package Instructions 

### * * * Attn Efficacy Reviewer: Please conduct an efficacy review ofthe attached package in support ofthe proposed product. Contact Rosanna Louie-Juzwiak at 308.0037 wilh any questions. Attachments:

- cover letter

- draft label

- data matrix Decision #: 438358 DP 

### #: (382779) PRIA Parent DP#: Submission #: 880181 

### DATA PACKAGE BEAN SHEET Date: 05-0ct-2010 Page t of2



### * * * Registration Information 

### * * * Registration:**~~1!::~Ylt:.~~~~GJ;~~NI:~J:H~BQ_~_'-~_~J~fLLA~t~'-QUEEZE -ON**  FOR DO_G§ Company:**?~** 17**_-_~~~§~!i!~-!:ET ~~~~~~Q~~~!S,_!NC.**  _ Risk Manager: RM)O

- Richard Gebken

- (703)**3~-.:-~~9_1_!3.<:I<:I~~_f_'(]** __**§.:?:.~~_~~** 

### _ Risk Manager Reviewer: Rosanna Louie RlOUIE Senl Date: Calculated Due Date: 23-Mar-2011 Edited Due Date:

Action Desc: (R310) NEW**PRODUC~~ON-YAS"I Tf¥.C!5j!ti~~~Q~_!3.~Y.~~~_2~_~~.2g9g_!_~!:!~_~~~_,** 

Ingredients: 

### ! 291**~:!.cXipr~~J!@~~~** 

### _



### * * * Data Package Information 

### * * * Expedite: 

### 0 Yes. No Dale Sen!: 05-0ct-2010 Due Back: OP Ingredienl: 129032, Pyriproxyfen**!?~~~!~£i~~_~il** 

### ._. _ DPTitle:**~_~!!_:RU_f3___=_~!!!.~_~9:'.~~Je~** _ CSF Included: 

### 0 Yes. No Label Included: • Yes 

### 0 No Parenl DP #:

Date In Date Out Last Possible Science Due Date: 21-Feb-2011 Team Name: Efficacy (IS) Science Due Date: Reviewer Name: Sub Data Package Due Dale:

_ Contractor Name:



### * * * Studies Sent for Review 

### * * *
Printed on Page 2



### * * * Additional Data Package for this Decision 

### * * * Can be printed on its own page


### * * * Data Package Instructions 

### * * * Attn Efficacy Reviewer: Please conduct an efficacy review ofthe attached package in support ofthe proposed product. Contact Rosanna Louie-Juzwiak at 308.0037 wilh any questions. Attachments:

- cover letter

- draft label

- data matrixDP#: (382779) Page 2

...... Studies Sent for Review""

.. Decision#: (438358)

810.3300rrreatments to control pests of humans and pets 45620501

43121114

45612701 43121116

4312t115

46346601

48129610

43121117

45620505

48t29611

43121122

43121118

45866902

45620504 Pengo, G,; Pollmeier, M.; Barrick, R (2000) An Efficacy Study of Frontline Spray, Frontline Top Spot, and ML-2,095,988 509T, for the Treatment and Control ofTrichodectes canis in the Dog: Final Report: Lab Project Number: PR&D 002210t, PR&D 00221. Unpublished study prepared by Centro Veterinario Oriolo. 24 p. {OPPTS 81 0.3300} Everett, R; Cunningham, J. (1993) A Dose Titration Study to Determine the Optimal Spray Concentration of RM 1601 for Long Term Control ofthe Cat Flea Ctenocephalides felis and the Brown Dog Tick Rhipicephalus sanguineus in the Dog: Revised: Lab Project Number: RMD 292: P/214LT. Unpublished study prepared byAgresearch Consultants. 53 p. Ahmed, Z. (2002) StUdy Summaries: Frontline Plus For Dogs. Unpublished study prepared by Merial. 40 p. Everett, R,; Cunningham, J. (1993) A Comparative Evaluation of Two Treatment Regimes Using RM 1601 Sprayfor Control ofthe Cat Flea Ctenocephalides felis on the Dog: Revised: Lab Project Number. RMD 692: P/222LT. Unpublfshed study prepared by Agresearch Consultants, Inc. 40 p. Cruthers, L. (t993) Product Performance: A Dose Confirmation Study to Verify the Optimal Spray Concentration of RM 1601 for Long Residual Control of the Cat Flea (Ctenocephalides felis) and the Brown Dog Tick (Rhipicephalus sanguineus) in the Dog: Revised: Lab Project Number: 9251: PI215LT. Unpublished study prepared by Professional Labs and Research Services, Inc. 51 p. Cruthers, L. (2003) Dose Titration of a Pyriproxyfen Spot.On Formulation For Flea Ova Sterilization. Project Number: PLRS/0242. Unpublished Study Prepared By Professional Laboratory & Research Services, Inc. 53 p. Sharp, M. (2009) Immediate Efficacy ofa Combined Application of 81 0.3300rrreatments to control Frontline Plus with Cyphenothrin as a Squeeze-On Against Fleas pests of humans and pets (Ctenocephalides felis) and Ticks (Rhipicephalus sanguineus) on Dogs: Analyses of Data Conclusions. Project Number: MS/1641D. Unpublished study prepared by Sharp Veterinary Research. 24 p. McCall, J,; McTier, T. (1993) Laboratory Evaluation of RM t601 Spray for Control Dermacentor variabilis and Rhipecephalus sanguineus on the Dog: Lab Project Number: RMrrKSI93/1 L: PS1229LT. Unpublished study prepared byTRS Labs, Inc. t8 p. Gaxiola, S.; Alva, R; Irwin, J. (2001) PR & 00052301: Frontline Spray/Frontline Spot-On/ML-2, 095, 988 509TlDogslSolutionrropical: Final Report: Lab Project Number: PR&D 0052301, PR&D 00523. Unpublished study prepared by University of Sinaloa. 40 p. (DPPTS 810.3300} Sharp, M. (2010) Immediate Efficacy Following Application of Frontline with Cyphenothrin Squeeze-On Against Fleas (ctenocephalides felis) and Ticks (Rhipicephalus sanguineus) on Dogs: Analyses of Data Conclusions. Project Number: MS/183D. Unpublished study prepared by Sharp Veterinary Research. 29 p. Cruthers, L. (1993) Efficacy of RM1601C at3 mllkg and 6 mllkg Against Ixodes scapularisldammini Nymphs, Dermacentor variabilis Nymphs, Amblyomma amerlcanum Nymphs, Rhipicephalus sanguineus Nymphs, and Ctenocephalides felides Adults Using Treated Dog Hair as the Testing Substrate: Revised: Lab Project Number: 9320: P/225LT. Unpublished study prepared by Professional Lab and Research Services, Inc. 28 p. Everett, R; Cunningham, J. (t993) An Investigation Study to Evaluate the Effect of Bathing of Laboratory Dogs on the Efficacy of RM1601 Spray: Revised: Lab Project Number: RMD 592: P/220LT. Unpublished study prepared byAgresearch Consultants, Inc. 43 p. McCall, J.; Alva, R; Irwin, J.; et a1. (2002) A StUdy to Evaluate the Efficacy of Frontline Plus for Control of Mosquitoes, Aedes aegypti, on Dogs: Final Report: Lab Project Number: PR&D 0055201. Unpublished study prepared by TRS Labs, Inc. 24 p. (OPPTS 81 0.3300} Marchiondo, A. (2001) PR & 0 002410t: Frontline Spray/Frontline Spot-On/ML-2, 095, 988 509T/DogslSolutionrropical: Final Report: Lab Project Number: PR&D 0024101: PR&D 00241. Unpublished study prepared by Slillmeadow, Inc. 29 p. {DPPTS 810.3300) DP#: (382779) Page 2

...... Studies Sent for Review""

.. Decision#: (438358)

810.3300rrreatments to control pests of humans and pets 45620501

43121114

45612701 43121116

4312t115

46346601

48129610

43121117

45620505

48t29611

43121122

43121118

45866902

45620504 Pengo, G,; Pollmeier, M.; Barrick, R (2000) An Efficacy Study of Frontline Spray, Frontline Top Spot, and ML-2,095,988 509T, for the Treatment and Control ofTrichodectes canis in the Dog: Final Report: Lab Project Number: PR&D 002210t, PR&D 00221. Unpublished study prepared by Centro Veterinario Oriolo. 24 p. {OPPTS 81 0.3300} Everett, R; Cunningham, J. (1993) A Dose Titration Study to Determine the Optimal Spray Concentration of RM 1601 for Long Term Control ofthe Cat Flea Ctenocephalides felis and the Brown Dog Tick Rhipicephalus sanguineus in the Dog: Revised: Lab Project Number: RMD 292: P/214LT. Unpublished study prepared byAgresearch Consultants. 53 p. Ahmed, Z. (2002) StUdy Summaries: Frontline Plus For Dogs. Unpublished study prepared by Merial. 40 p. Everett, R,; Cunningham, J. (1993) A Comparative Evaluation of Two Treatment Regimes Using RM 1601 Sprayfor Control ofthe Cat Flea Ctenocephalides felis on the Dog: Revised: Lab Project Number. RMD 692: P/222LT. Unpublfshed study prepared by Agresearch Consultants, Inc. 40 p. Cruthers, L. (t993) Product Performance: A Dose Confirmation Study to Verify the Optimal Spray Concentration of RM 1601 for Long Residual Control of the Cat Flea (Ctenocephalides felis) and the Brown Dog Tick (Rhipicephalus sanguineus) in the Dog: Revised: Lab Project Number: 9251: PI215LT. Unpublished study prepared by Professional Labs and Research Services, Inc. 51 p. Cruthers, L. (2003) Dose Titration of a Pyriproxyfen Spot.On Formulation For Flea Ova Sterilization. Project Number: PLRS/0242. Unpublished Study Prepared By Professional Laboratory & Research Services, Inc. 53 p. Sharp, M. (2009) Immediate Efficacy ofa Combined Application of 81 0.3300rrreatments to control Frontline Plus with Cyphenothrin as a Squeeze-On Against Fleas pests of humans and pets (Ctenocephalides felis) and Ticks (Rhipicephalus sanguineus) on Dogs: Analyses of Data Conclusions. Project Number: MS/1641D. Unpublished study prepared by Sharp Veterinary Research. 24 p. McCall, J,; McTier, T. (1993) Laboratory Evaluation of RM t601 Spray for Control Dermacentor variabilis and Rhipecephalus sanguineus on the Dog: Lab Project Number: RMrrKSI93/1 L: PS1229LT. Unpublished study prepared byTRS Labs, Inc. t8 p. Gaxiola, S.; Alva, R; Irwin, J. (2001) PR & 00052301: Frontline Spray/Frontline Spot-On/ML-2, 095, 988 509TlDogslSolutionrropical: Final Report: Lab Project Number: PR&D 0052301, PR&D 00523. Unpublished study prepared by University of Sinaloa. 40 p. (DPPTS 810.3300} Sharp, M. (2010) Immediate Efficacy Following Application of Frontline with Cyphenothrin Squeeze-On Against Fleas (ctenocephalides felis) and Ticks (Rhipicephalus sanguineus) on Dogs: Analyses of Data Conclusions. Project Number: MS/183D. Unpublished study prepared by Sharp Veterinary Research. 29 p. Cruthers, L. (1993) Efficacy of RM1601C at3 mllkg and 6 mllkg Against Ixodes scapularisldammini Nymphs, Dermacentor variabilis Nymphs, Amblyomma amerlcanum Nymphs, Rhipicephalus sanguineus Nymphs, and Ctenocephalides felides Adults Using Treated Dog Hair as the Testing Substrate: Revised: Lab Project Number: 9320: P/225LT. Unpublished study prepared by Professional Lab and Research Services, Inc. 28 p. Everett, R; Cunningham, J. (t993) An Investigation Study to Evaluate the Effect of Bathing of Laboratory Dogs on the Efficacy of RM1601 Spray: Revised: Lab Project Number: RMD 592: P/220LT. Unpublished study prepared byAgresearch Consultants, Inc. 43 p. McCall, J.; Alva, R; Irwin, J.; et a1. (2002) A StUdy to Evaluate the Efficacy of Frontline Plus for Control of Mosquitoes, Aedes aegypti, on Dogs: Final Report: Lab Project Number: PR&D 0055201. Unpublished study prepared by TRS Labs, Inc. 24 p. (OPPTS 81 0.3300} Marchiondo, A. (2001) PR & 0 002410t: Frontline Spray/Frontline Spot-On/ML-2, 095, 988 509T/DogslSolutionrropical: Final Report: Lab Project Number: PR&D 0024101: PR&D 00241. Unpublished study prepared by Slillmeadow, Inc. 29 p. {DPPTS 810.3300)

### Efficacy Review Date: December 6, 2010 Efficacy Reviewer: Clayton Myers, Ph.D., Entomologist, RD-IB AO 111 

### -'ers.cla 'ton((i)e a.QOv

. ? A' 

### 703-347-8874 \
RiskManager Rev.: Rosanna Louie Products: EPAReg.#: A.I.'s: Decision #s: DP#s: Submission: 

### MRIDs: 

## i'L,l0f Sergeant's Fipronil 

### + Cyphenothrin 

### +Methoprene'Squeeze-on for Dogs 2517-RUR Fipronil (9.8%), Cyphenothrin (5.0%), Pyriproxyfen (2.0%) 438358 382779 R3l0, New Products, RD Science Review Submitted: 48129609,48129610,48129611,48129612,48129613,



### GLP:



### MRID 48129609 Cited:

No 43121114,43121115,43121116,43121117,43121118, 43121122,43577712,45612701,45620501,45620504, 45620505,45620506,45628201,45866902,46346601, 47849608

Title: Overview and Summary ofFiproniVCyphenothrin Dog Efficacy for Sergeant's Fipronil 

### + Cyphenothrin Squeeze-On for Dogs (Overview ofother submissions). Guideline: 

### OPPTS 810.3300 Study Summary ofthe Results: This submission is an overall summary and clarification ofthe other submitted MRIDs associated with this application Entomologist's ObservationslDiscussion: Supplementary Infonnation Efficacy Review Date: December 6, 2010 Efficacy Reviewer: Clayton Myers, Ph.D., Entomologist, RD-IB AO 111 

### -'ers.cla 'ton((i)e a.QOv

. ? A' 

### 703-347-8874 \
RiskManager Rev.: Rosanna Louie Products: EPAReg.#: A.I.'s: Decision #s: DP#s: Submission: 

### MRIDs: 

## i'L,l0f Sergeant's Fipronil 

### + Cyphenothrin 

### +Methoprene'Squeeze-on for Dogs 2517-RUR Fipronil (9.8%), Cyphenothrin (5.0%), Pyriproxyfen (2.0%) 438358 382779 R3l0, New Products, RD Science Review Submitted: 48129609,48129610,48129611,48129612,48129613,



### GLP:



### MRID 48129609 Cited:

No 43121114,43121115,43121116,43121117,43121118, 43121122,43577712,45612701,45620501,45620504, 45620505,45620506,45628201,45866902,46346601, 47849608

Title: Overview and Summary ofFiproniVCyphenothrin Dog Efficacy for Sergeant's Fipronil 

### + Cyphenothrin Squeeze-On for Dogs (Overview ofother submissions). Guideline: 

### OPPTS 810.3300 Study Summary ofthe Results: This submission is an overall summary and clarification ofthe other submitted MRIDs associated with this application Entomologist's ObservationslDiscussion: Supplementary Infonnation

### MRID 48129810 Title: Immediate Efficacy ofa Combined Application ofFrontline Plus with Cyphenothrin as a Squeeze-on against Fleas 

### (Ctenocephalisfelis) and Ticks 

### (Rhipicephalus sanguineus) on Dogs. 

### Guideline: OPPIS 810.3300 Materials and Methods: Cyphenothrin was added to Frontline plus at 3 fates (5%, 10%, and 15%) 

### for efficacy evaluations. Dose volumes applied were based on the Frontline label, but 

### dilution was nottaken into account for the existing fipronil, therefore fipronil dosage was slightly lowerthan that ofFrontline alone. 18 dogs were allocated to 6 groups of3 dogs each. Group 1, untreated control; Group 2, Frontline alone, Groups 3-5 Frontline plus cyphenothrin at described rates. Dogs were infested with 100 fleas and 50 ticks one day before treatment, and again at 7 and 14 days aftertreatment. Counts were made at 1 and 4 hours posttreatment and also on day 14 at 1 and 4 hours postplacement-this was to measure speed ofkill and/or repellency. Counts were also made at 24 and 48 hours after initial infestation and all**re~** infestations. Parasites were not removed until the final count. Mortality was calculated using Abbott's fonnula. For speed ofkilVrepellence, the number ofkilledJrepelled fleas on the liner below each treated dog was divided by the total number offleas placed on the dog (all x 100), adjusted for 'nonnal' attrition on control dogs. Study Summary ofthe Results: 1. Mean efficacy against fleas and ticks exceeded 90% when assessed at**1~2** days after treatment or reinfestation with parasites, through 14 days aftertreatment. 2. Immediate efficacy on fleas (i.e. kill/repellence within 4 hours oftreatment) ranged from 9-74% for 1**~4** hours immediately aftertreatment. With reinfestations after 14 days from treatment, efficacy exceeded 99% within 4 hours for all treatments that included cyphenothrin. 3. Immediate efficacy on ticks ranged from 2-64% for**1~2** hours immediately after treatment. With reinfestations after 14 days from treatment, efficacy exceeded 95% within 1 hour, forthe lowestpercentage ofcyphenothrin treatment, and exceeded 84% for all treatments. Entomologist's ObservationslDicussion: 1. Efficacy against fleas and ticks was adequate to support controls claims through 14 days aftertreatment. 2. While immediate efficacy against fleas and ticks was enhanced when assessed at 1 and 4 hours after treatment (or reinfestation), the immediate efficacy did not exceed 90% with any consistency for the treatments evaluated immediately after treatment. However, after 14 days, this immediate efficacy was observed for reinfestations of both fleas and ticks. This is likely due to the more complete spread ofthe spot-on material throughout the animal coat at 14 days. Claims for killing (or'starts killing') within hours would be supported by this data, but not immediately aftertreatment of the animals. 

### MRID 48129810 Title: Immediate Efficacy ofa Combined Application ofFrontline Plus with Cyphenothrin as a Squeeze-on against Fleas 

### (Ctenocephalisfelis) and Ticks 

### (Rhipicephalus sanguineus) on Dogs. 

### Guideline: OPPIS 810.3300 Materials and Methods: Cyphenothrin was added to Frontline plus at 3 fates (5%, 10%, and 15%) 

### for efficacy evaluations. Dose volumes applied were based on the Frontline label, but 

### dilution was nottaken into account for the existing fipronil, therefore fipronil dosage was slightly lowerthan that ofFrontline alone. 18 dogs were allocated to 6 groups of3 dogs each. Group 1, untreated control; Group 2, Frontline alone, Groups 3-5 Frontline plus cyphenothrin at described rates. Dogs were infested with 100 fleas and 50 ticks one day before treatment, and again at 7 and 14 days aftertreatment. Counts were made at 1 and 4 hours posttreatment and also on day 14 at 1 and 4 hours postplacement-this was to measure speed ofkill and/or repellency. Counts were also made at 24 and 48 hours after initial infestation and all**re~** infestations. Parasites were not removed until the final count. Mortality was calculated using Abbott's fonnula. For speed ofkilVrepellence, the number ofkilledJrepelled fleas on the liner below each treated dog was divided by the total number offleas placed on the dog (all x 100), adjusted for 'nonnal' attrition on control dogs. Study Summary ofthe Results: 1. Mean efficacy against fleas and ticks exceeded 90% when assessed at**1~2** days after treatment or reinfestation with parasites, through 14 days aftertreatment. 2. Immediate efficacy on fleas (i.e. kill/repellence within 4 hours oftreatment) ranged from 9-74% for 1**~4** hours immediately aftertreatment. With reinfestations after 14 days from treatment, efficacy exceeded 99% within 4 hours for all treatments that included cyphenothrin. 3. Immediate efficacy on ticks ranged from 2-64% for**1~2** hours immediately after treatment. With reinfestations after 14 days from treatment, efficacy exceeded 95% within 1 hour, forthe lowestpercentage ofcyphenothrin treatment, and exceeded 84% for all treatments. Entomologist's Observations/Dicussion: 1. Efficacy against fleas and ticks was adequate to support controls claims through 14 days aftertreatment. 2. While immediate efficacy against fleas and ticks was enhanced when assessed at 1 and 4 hours after treatment (or reinfestation), the immediate efficacy did not exceed 90% with any consistency for the treatments evaluated immediately after treatment. However, after 14 days, this immediate efficacy was observed for reinfestations of both fleas and ticks. This is likely due to the more complete spread ofthe spot-on material throughout the animal coat at 14 days. Claims for killing (or'starts killing') within hours would be supported by this data, but not immediately aftertreatment of the animals.

### MRID 48129811 Title: Immediate Efficacy Following Application ofFrontline 

### with Cyphenothrin**Squeeze~on** 

### against Fleas 

### (Ctenocephalisfelis) and Ticks 

### (Rhipicephalus sanguineus) on Dogs. 

### Guideline: OPPTS 810.3300 Materials and Methods: Cyphenothrin was added to Frontline plus atthe rate ofapproximately 5% (4.76% cyphenothrin) for efficacy evaluations. Dose volumes applied were based on the Frontline label, but dilution was nottaken into account for the existing tipronil, therefore tipronil dosage was slightly lowerthan that ofFrontline alone. 18 dogs were allocated to 3 groups of6 

### dogs each. Group 1, untreated control; Group 2, Frontline+cyphenothrin, Groups 3, Frontline alone

.. Dogs were infested 

### with 100 fleas and 50 ticks one day before treatment, and again at 7, 14,21, and 28 days aftertreatment. Counts were made at 1 and 4 hours posttreatment and also after every reinfestation-this was to measure speed ofkill and/orrepellency. Counts were also made at 24 and 48 hours after initial infestation and all re-infestations. Parasites were not removed until the final count. Mortality was calculated using Abbott's formula. For speed of kill/repellence, the number ofkilled/repelled fleas on the liner below each treated dog was divided by the total numberoffleas placed on the dog (all x 100), adjusted for 'nonnal' attrition on control dogs. Study Summary ofthe Results:
1. 

### Mean efficacy against fleas and ticks exceeded 90% when assessed at 1-2 days after treatment orreinfestation with parasites, through 28 days after treatment. 2. Immediate efficacy on fleas (i.e. killirepellence within 4 hours oftreatment) ranged from 9-68% for I-4 hours immediately after treatment. With reinfestations after 7, 14,21, and 28 days from treatment, efficacy exceeded 90% within 4 hours for all treatments that included cyphenothrin, butdid not exceed 90% within 1 hour after reinfestation. 3. Immediate efficacy on ticks ranged from**5~75%** 

### for**I~2** 

### hours immediately after treatment. With reinfestations after 7,14,21, and 28 days from treatment, efficacy exceeded 90% within 4 hours for all dates. For 21 and 28 days from treatment, adequate efficacy was observed within 1 hour ofreinfestation. Entomologist's ObsenrationslDicussion: 1. Efficacy against fleas and ticks was adequate to supportcontrols claims through 28 days (one month) after treatment. 2. While immediate efficacy against fleas and ticks was marginally enhanced when assessed at 1 and 4 hours after treatment (or reinfestation), the immediate efficacy did not exceed 90% with any consistency for the treatments evaluated immediately after treatment. However, after 7 days, this immediate efficacy was observed for reinfestations ofboth fleas and ticks. This is likely due to the more complete spread ofthe spot-on material throughoutthe animal coat at 7+ days. Claims for killing (or MRID 48129811 Title: Immediate Efficacy Following Application ofFrontline 

### with Cyphenothrin**Squeeze~on** 

### against Fleas 

### (Ctenocephalisfelis) and Ticks 

### (Rhipicephalus sanguineus) on Dogs. 

### Guideline: OPPTS 810.3300 Materials and Methods: Cyphenothrin was added to Frontline plus atthe rate ofapproximately 5% (4.76% cyphenothrin) for efficacy evaluations. Dose volumes applied were based on the Frontline label, but dilution was nottaken into account for the existing tipronil, therefore tipronil dosage was slightly lowerthan that ofFrontline alone. 18 dogs were allocated to 3 groups of6 

### dogs each. Group 1, untreated control; Group 2, Frontline+cyphenothrin, Groups 3, Frontline alone

.. Dogs were infested 

### with 100 fleas and 50 ticks one day before treatment, and again at 7, 14,21, and 28 days aftertreatment. Counts were made at 1 and 4 hours posttreatment and also after every reinfestation-this was to measure speed ofkill and/orrepellency. Counts were also made at 24 and 48 hours after initial infestation and all re-infestations. Parasites were not removed until the final count. Mortality was calculated using Abbott's formula. For speed of kill/repellence, the number ofkilled/repelled fleas on the liner below each treated dog was divided by the total numberoffleas placed on the dog (all x 100), adjusted for 'nonnal' attrition on control dogs. Study Summary ofthe Results:
1. 

### Mean efficacy against fleas and ticks exceeded 90% when assessed at 1-2 days after treatment orreinfestation with parasites, through 28 days after treatment. 2. Immediate efficacy on fleas (i.e. killirepellence within 4 hours oftreatment) ranged from 9-68% for I-4 hours immediately after treatment. With reinfestations after 7, 14,21, and 28 days from treatment, efficacy exceeded 90% within 4 hours for all treatments that included cyphenothrin, butdid not exceed 90% within 1 hour after reinfestation. 3. Immediate efficacy on ticks ranged from**5~75%** 

### for**I~2** 

### hours immediately after treatment. With reinfestations after 7,14,21, and 28 days from treatment, efficacy exceeded 90% within 4 hours for all dates. For 21 and 28 days from treatment, adequate efficacy was observed within 1 hour ofreinfestation. Entomologist's ObsenrationslDicussion: 1. Efficacy against fleas and ticks was adequate to supportcontrols claims through 28 days (one month) after treatment. 2. While immediate efficacy against fleas and ticks was marginally enhanced when assessed at 1 and 4 hours after treatment (or reinfestation), the immediate efficacy did not exceed 90% with any consistency for the treatments evaluated immediately after treatment. However, after 7 days, this immediate efficacy was observed for reinfestations ofboth fleas and ticks. This is likely due to the more complete spread ofthe spot-on material throughoutthe animal coat at 7+ days. Claims for killing (or

### 'starts killing') within hours would be supported by this data, but not immediately after treatment ofthe animals.

MRID 48129812 Title: Immediate Efficacy Following Application ofFrontline Plus with Cyphenothrin Squeezeon against Fleas 

### (Ctenocephalisjelis) and Ticks 

### (Rhipicephalus sanguineus) on Dogs. 

### Guideline: OPPTS 810.3300 Materials and Methods: Cyphenothrin was added to Frontline plus atthe rate ofapproximately 5% (4.76% cyphenothrin) for efficacy evaluations. Dose volumes applied were based on the Frontline label, but dilution was not taken into account for the existing fipronil, therefore fipronil dosage was slightly lower than that ofFrontline alone. 18 dogs were allocated to 3 groups of6 dogs each. Group 1, untreated control; Group 2, Frontline+cyphenothrin, Groups 3, Frontline alone

.. Dogs were infested with 100 fleas and 50 ticks one day before treatment, and again at 7, 14,21,28, and 35 days aftertreatment. Counts were made at 1 and 4 hours posttreatment and also after every reinfestation-this was to measure speed ofkill and/orrepellency. Counts were also made at 24 and 48 hours after initial infestation and all re-infestations. Parasites were not removed until the final count. Mortality was calculated using Abbott's formula. For speed of kilVrepellence, the number ofkilled/repelled fleas on the liner below each treated dog was divided by the total number offleas placed on the dog (all x 100), adjusted for 'normal' attrition on control dogs. Study Summary ofthe Results: 1. Mean efficacy against fleas and ticks exceeded 90% when assessed at 1

### M2 days after treatment or reinfestation with parasites, through 35 days aftertreatment. 2. Immediate efficacy on fleas (i.e. kill/repellence within 4 hours oftreatment) ranged from 0-75% for 1-4 hours immediately aftertreatment. With reinfestations after 7, 14, 21, 28, and 35 days from treatment, efficacy exceeded 90% within 4 hours for all only the 7 day reinfestation. Efficacy did not exceed 90% within 4**hour~** 

### for reinfestations on days 14, 21,28, or 35 days aftertreatment. 3. Immediate efficacy on ticks ranged from 11-71 % 

### for 1-4 hours immediately after treatment. With reinfestations after 7, 14,21, and 28 days from treatment, efficacy exceeded 90% within 4 hours for only the 7 day reinfestation. Efficacy did not exceed 90% within 4 hours for reinfestations on days 14,21,28, or 35 days after treatment. Entomologist's ObservationslDicussion: 1. Efficacy againstfleas and ticks was adequate to support controls claims through 35 days (one month) after treatment. 2. While immediate efficacy against fleas and ticks was marginally enhanced when assessed at 1 and 4 hours aftertreatment (or reinfestation) comparedto fipronil alone, 'starts killing') within hours would be supported by this data, but not immediately after treatment ofthe animals.

MRID 48129812 Title: Immediate Efficacy Following Application ofFrontline Plus with Cyphenothrin Squeezeon against Fleas 

### (Ctenocephalisfeiis) and Ticks 

### (Rhipicephalus sanguineus) on Dogs. 

### Guideline: OPPTS 810.3300 Materials and Methods: Cyphenothrin was added to Frontline plus atthe rate ofapproximately 5% (4.76% cyphenothrin) for efficacy evaluations. Dose volumes applied were based on the Frontline label, but dilution was not taken into account for the existing fipronil, therefore fipronil dosage was slightly lower than that ofFrontline alone. 18 dogs were allocated to 3 groups of6 dogs each. Group 1, untreated control; Group 2, Frontline+cyphenothrin, Groups 3, Frontline alone

.. Dogs were infested with 100 fleas and 50 ticks one day before treatment, and again at 7, 14,21,28, and 35 days aftertreatment. Counts were made at 1 and 4 hours posttreatment and also after every reinfestation-this was to measure speed ofkill and/orrepellency. Counts were also made at 24 and 48 hours after initial infestation and all re-infestations. Parasites were not removed until the final count. Mortality was calculated using Abbott's formula. For speed of kilVrepellence, the number ofkilled/repelled fleas on the liner below each treated dog was divided by the total number offleas placed on the dog (all x 100), adjusted for 'normal' attrition on control dogs. Study Summary ofthe Results: 1. Mean efficacy against fleas and ticks exceeded 90% when assessed at 1

### M2 days after treatment or reinfestation with parasites, through 35 days aftertreatment. 2. Immediate efficacy on fleas (i.e. kill/repellence within 4 hours oftreatment) ranged from 0-75% for 1-4 hours immediately aftertreatment. With reinfestations after 7, 14, 21, 28, and 35 days from treatment, efficacy exceeded 90% within 4 hours for all only the 7 day reinfestation. Efficacy did not exceed 90% within 4**hour~** 

### for reinfestations on days 14, 21,28, or 35 days aftertreatment. 3. Immediate efficacy on ticks ranged from 11-71 % 

### for 1-4 hours immediately after treatment. With reinfestations after 7, 14,21, and 28 days from treatment, efficacy exceeded 90% within 4 hours for only the 7 day reinfestation. Efficacy did not exceed 90% within 4 hours for reinfestations on days 14,21,28, or 35 days after treatment. Entomologist's ObservationslDicussion: 1. Efficacy againstfleas and ticks was adequate to support controls claims through 35 days (one month) after treatment. 2. While immediate efficacy against fleas and ticks was marginally enhanced when assessed at 1 and 4 hours aftertreatment (or reinfestation) comparedto fipronil alone,

### the immediate efficacy did not exceed 90% with any consistency for the treatments evaluated immediately 1-4 hours after initial treatment or reinfestation beyond 7 days aftertreatment. This data does not support any claims for faster kill or repellence due to the addition ofcyphenothrin.

MID» 48129813 Title: Comparative efficacy evaluation ofSergeant's**Squeeze~on** 

### and Frontline Plus for the treatment ofadult cat flea (Ctenocephalidesfelis) 

### and tick (Haemaphysalis elliplica, Rhipicephalus sanguineus, 

### andDermacentor variabilis) 

### infestations on dogs. Guideline: 

### OPPTS 810.3300 Materials and 

### Methods: Cyphenothrin was added to Seargeant's**Fipronil~Methroprene** 

### formulation Frontline plus atthe rate ofapproximately 5% for efficacy evaluations. This treatment was compared to fipronil-methoprene alone, and apositive control, Merial's Frontline Plus. Dose volumes applied were based on a titration by which dogs received 0.067 mL/kg body weight, to simulate the dosing at the high end ofeach respective weight class. Dogs were subgrouped by weightclass with 6 dogs in each subclass (split overtime to 3 dogs ofeach class in 2 consecutive studies). Group 1, untreated control; Group 2, Fipronil+Methoprene, Group 3, FiproniI+Methoprene+cyphenothrin, Group 4, Frontline Plus. Dogs were infested with 100 fleas and 50 ticks one day before treatment, and again at 7, 14,21, and 28 days aftertreatment. Counts were made at 1 and 4 hours post treatment and also after every reinfestation-this was to measure speed ofkill and/or repellency. Counts were also made at 24 and 48 hours after initial infestation and all re-infestations. Parasites were not removed until the final count. Mortality was calculated using Abbott's formula. For speed ofkill/repellence, 

### the number of killed/repelled fleas on the liner below each treated dog was divided by the total number offleas placed on the dog (all x 100), adjusted for 'normal' attrition on control dogs. Study Summary ofthe Results: 1. Mean efficacy against fleas exceeded 90% when assessed at 2 days after treatment or reinfestation with parasites, through 28 days after treatment. 2. Immediate group mean efficacy on ticks (all species) overall means were all below 90%. Entomologist's ObservationslDicussion: 1. Efficacy against fleas and ticks was adequate to support controls general claims through 35 days (one month) aftertreatment. 2. No immediate efficacy claims (i.e., within 1-4 hours ofapplication or reinfestation by parasites) are supported by this data. the immediate efficacy did not exceed 90% with any consistency for the treatments evaluated immediately 1-4 hours after initial treatment or reinfestation beyond 7 days aftertreatment. This data does not support any claims for faster kill or repellence due to the addition ofcyphenothrin.

MID» 48129813 Title: Comparative efficacy evaluation ofSergeant's**Squeeze~on** 

### and Frontline Plus for the treatment ofadult cat flea (Ctenocephalidesfelis) 

### and tick (Haemaphysalis elliptica, Rhipicephalus sanguineus, 

### andDermacentor variabilis) 

### infestations on dogs. Guideline: 

### OPPTS 810.3300 Materials and 

### Methods: Cyphenothrin was added to Seargeant's**Fipronil~Methroprene** 

### formulation Frontline plus atthe rate ofapproximately 5% for efficacy evaluations. This treatment was compared to fipronil-methoprene alone, and apositive control, Merial's Frontline Plus. Dose volumes applied were based on a titration by which dogs received 0.067 mL/kg body weight, to simulate the dosing at the high end ofeach respective weight class. Dogs were subgrouped by weightclass with 6 dogs in each subclass (split overtime to 3 dogs ofeach class in 2 consecutive studies). Group 1, untreated control; Group 2, Fipronil+Methoprene, Group 3, FiproniI+Methoprene+cyphenothrin, Group 4, Frontline Plus. Dogs were infested with 100 fleas and 50 ticks one day before treatment, and again at 7, 14,21, and 28 days aftertreatment. Counts were made at 1 and 4 hours post treatment and also after every reinfestation-this was to measure speed ofkill and/or repellency. Counts were also made at 24 and 48 hours after initial infestation and all re-infestations. Parasites were not removed until the final count. Mortality was calculated using Abbott's formula. For speed ofkill/repellence, 

### the number of killed/repelled fleas on the liner below each treated dog was divided by the total number offleas placed on the dog (all x 100), adjusted for 'normal' attrition on control dogs. Study Summary ofthe Results: 1. Mean efficacy against fleas exceeded 90% when assessed at 2 days after treatment or reinfestation with parasites, through 28 days after treatment. 2. Immediate group mean efficacy on ticks (all species) overall means were all below 90%. Entomologist's ObservationslDicussion: 1. Efficacy against fleas and ticks was adequate to support controls general claims through 35 days (one month) aftertreatment. 2. No immediate efficacy claims (i.e., within 1-4 hours ofapplication or reinfestation by parasites) are supported by this data.

### Overall Review ofLabel Claims and Directions: Based upon submitted efficacy data, claims are supported for fleas andticks through 35 days. Claims for immediate efficacy are not supported except to state "starts killing within hours" or "starts killing in as little as one hour", Repellence claims for fleas and ticks are not supported and must be removed from the label. Kill claims against flea eggs or larvae, are supported. Control claims against flea eggs or larvae, or claims against breaking the flea life cycle are supported for up to 9 weeks aftertreatment.

Line bv Line Review ofLabel Efficacy Claims Kills fleas, flea eggs, ticks, chewing lice & 

### mosquitoes: Acceptable 1/<i' JY;",-\,y\ 

### Controls flea reinfestationfor up to [12 weeks]: Acceptable \.}¥\OLL{,4::!;;. J

,.. O,,£:dt1L \.\l1( ''''-'

. 

### Fast Acting: Unacceptable Kills ticks including those that may transmit Lyme disease: Acceptable Dogs canbe bathed 24 hours after treatment: Unacceptable Waterproof: Acceptable Long Lasting: Acceptable Research demonstrates that [brand name] kills adult fleas, flea eggs, larvae and pupae for up to 3 months): Claim against 'pupae' must be deleted, as no data was submitted indicating the product kills flea pupae exposed to residue. [brand name] prevents development ofall flea stages for up to 3 months: Acceptable only if duration is revised to '[63 days] [9 weeks]. Kills fleas, ticks, mosquitoes. (chewing) lice, flea eggs, larvae. and pupae: Claims against pupae must be deleted. Prevents all flea stages (adult fleas, flea eggs, flea pupae, and flea larvae): Claims againstpupae must be deleted. Ifdog is a highrisk for flea re-infestation once a month application may be needed: Acceptable. Once a month treatment is recommended: Acceptable. A once monthly application is recommended for chewing lice: Acceptable. Rapidly eliminates infestations with chewing lice: Acceptable. Overall Review ofLabel Claims and Directions: Based upon submitted efficacy data, claims are supported for fleas andticks through 35 days. Claims for immediate efficacy are not supported except to state "starts killing within hours" or "starts killing in as little as one hour", Repellence claims for fleas and ticks are not supported and must be removed from the label. Kill claims against flea eggs or larvae, are supported. Control claims against flea eggs or larvae, or claims against breaking the flea life cycle are supported for up to 9 weeks aftertreatment.

Line bv Line Review ofLabel Efficacy Claims Kills fleas. flea eggs. ticks. chewing lice & 

### mosquitoes: Acceptable 1/<i' JY;",-\,y\ 

### Controls flea reinfestationfor up to [12 weeks]: Acceptable \.}¥\OLL{,4::!;;. J

,.. O,,£:dt1L \.\l1( ''''-'

. 

### Fast Acting: Unacceptable Kills ticks including those that may transmit Lyme disease: Acceptable Dogs canbe bathed 24 hours after treatment: Unacceptable Waterproof: Acceptable Long Lasting: Acceptable Research demonstrates that [brand name] kills adult fleas. flea eggs. larvae and pupae for up to 3 months): Claim against 'pupae' must be deleted, as no data was submitted indicating the product kills flea pupae exposed to residue. [brand name] prevents development ofall flea stages for up to 3 months: Acceptable only if duration is revised to '[63 days] [9 weeks]. Kills fleas, ticks, mosquitoes. (chewing) lice, flea eggs, larvae. and pupae: Claims against pupae must be deleted. Prevents all flea stages (adult fleas, flea eggs, flea pupae, and flea larvae): Claims againstpupae must be deleted. Ifdog is a highrisk for flea re-infestation once a month application may be needed: Acceptable. Once a month treatment is recommended: Acceptable. A once monthly application is recommended for chewing lice: Acceptable. Rapidly eliminates infestations with chewing lice: Acceptable.

### Monthly flea. tick, mosquito. lice. and flea egg protection: Acceptable. Monthly flea, tick. mosquito. and lice protection: Acceptable. Kills flea eggs (larvae] [pupae] for up more than [63 days] [9 weeks]: Acceptable except claim against 'pupae' must be deleted, as no data was submitted indicating the product kills flea pupae exposedto residue. Aids in control ofsarcoptic mange: Acceptable. Kills fleas. ticks. mosquitoes. flea eggs. and lice: Acceptable [Seven] [7] Way Protection! Kills fleas, ticks. mosquitoes, lice flea eggs. flea larvae. & 

### flea pupae: '7-way' is an unacceptable nebulous claim. Claims against flea pupae must be deleted 6 [Six] Way Protection! Kills fleas, ticks, mosquitoes. lice, flea eggs & 

### flea larvae: '6-way' is an unacceptable nebulous claim. [4 Week] [Flea and Tick & 

### Treatment]: Acceptable Four (4) Week Flea. Tick. Mosquitoe and Lice Control: Acceptable With Nylar® Insect Growth Regulator which Breaks the Flea Life Cycle: Acceptable With Nylar® to Break Flea Life Cycle: Acceptable With Insect Growth Regulatorto Break Flea Life Cycle: Acceptable Dual Action [l]: Fipronil with Nylar® lGREffectively Breaks the Flea Life Cycle: Acceptable. Dual Action [I]: Effectively Breaks the Flea Life Cycle[l]: Acceptable Best ifused year round!: Acceptable Kills Fleas Up to [4 weeks]![2 months] [3 months]: Acceptable (ICON showing 4 week protection): Acceptable 4 Week Dose!: Acceptable I Month Dose!: Acceptable Specially Formulated for Dogs and Puppies: Acceptable Kills FleaEggs & 

### Flea Larvaefor more than [63 days], [9 weeks]!: Acceptable Monthly flea. tick, mosquito. lice. and flea egg protection: Acceptable. Monthly flea, tick. mosquito. and lice protection: Acceptable. Kills flea eggs (larvae] [pupae] for up more than [63 days] [9 weeks]: Acceptable except claim against 'pupae' must be deleted, as no data was submitted indicating the product kills flea pupae exposedto residue. Aids in control ofsarcoptic mange: Acceptable. Kills fleas. ticks. mosquitoes. flea eggs. and lice: Acceptable [Seven] [7] Way Protection! Kills fleas, ticks. mosquitoes, lice flea eggs. flea larvae. & 

### flea pupae: '7-way' is an unacceptable nebulous claim. Claims against flea pupae must be deleted 6 [Six] Way Protection! Kills fleas, ticks, mosquitoes. lice, flea eggs & 

### flea larvae: '6-way' is an unacceptable nebulous claim. [4 Week] [Flea and Tick & 

### Treatment]: Acceptable Four (4) Week Flea. Tick. Mosquitoe and Lice Control: Acceptable With Nylar® Insect Growth Regulator which Breaks the Flea Life Cycle: Acceptable With Nylar® to Break Flea Life Cycle: Acceptable With Insect Growth Regulatorto Break Flea Life Cycle: Acceptable Dual Action [l]: Fipronil with Nylar® lGREffectively Breaks the Flea Life Cycle: Acceptable. Dual Action [I]: Effectively Breaks the Flea Life Cycle[l]: Acceptable Best ifused year round!: Acceptable Kills Fleas Up to [4 weeks]![2 months] [3 months]: Acceptable (ICON showing 4 week protection): Acceptable 4 Week Dose!: Acceptable I Month Dose!: Acceptable Specially Formulated for Dogs and Puppies: Acceptable Kills FleaEggs & 

### Flea Larvaefor more than [63 days], [9 weeks]!: Acceptable

### Prevents Flea Eggs From Developing Into Biting Adults: Acceptable Kills Ticks for Up to 14 weeks]!: Acceptable Kills [all stages of] DeerTicks (vector ofLyme Disease) for up to 4 weeks: Acceptable Kills Ticks (Including DeerTicks) for up to 4 weeks: Acceptable Kills [Brown]. [American.] [and Lone Stare] Dog Ticks for up to 4 weeks: Acceptable Kills Rhipicephalussanguineus 

### for up to 4 weeks: Acceptable When used monthly [brand name] completely breaks the flea life cycle and controls tick and chewing lice infestations: Acceptable Kills American Dog Ticks [(Dermacentor variabilis)] 

### for up to 4weeks!: Acceptable Apply once every [4 weeks]!: Acceptable 4 weeks Flea and Tick Treatment: Acceptable Once A Month Flea and Tick Treatment: Acceptable Kills Fleas and Ticks for up to 4 weeks!: Acceptable Kills all stages ofthe flea life cycle: Acceptable Kills fleas, Ticks, Flea Eggs & 

### Flea Larvae for up to 4 Weeks: Acceptable Kills mosquitoes: Acceptable Dogs can bebathed 24 hours after**squeeze~on** 

### is applied: Unacceptable Prevents and controls reinfestations: Unacceptable unless a pest and duration ofcontrol is associated (e.g., 'prevents and controls reinfestations oflisted pests for 1 month [4 weeks]'). BACK/SIDE CARTON LABEL-MASTER LABEL [brandname] containes Fiproni!. and the insect growth regulator (lOR) Nylar® to effectivelykill [and repel] Fleas. Ticks [(including those that may transmit Lyme Disease)]. andkills flea eggs, flea larvae, mosquitoes and (chewing) lice. The active ingredients in [brand name] work by collecting in the hairfollicles and skin oils. This product features a sustained-release formula that discharges from the animal's hairfollicles using the natural skin oils, resulting in fast acting [and long lasting] control ofFleas and Ticks [(in as little as one hour)]. [and kills mosquitoes] Prevents Flea Eggs From Developing Into Biting Adults: Acceptable Kills Ticks for Up to 14 weeks]!: Acceptable Kills [all stages of] DeerTicks (vector ofLyme Disease) for up to 4 weeks: Acceptable Kills Ticks (Including DeerTicks) for up to 4 weeks: Acceptable Kills [Brown]. [American.] [and Lone Stare] Dog Ticks for up to 4 weeks: Acceptable Kills Rhipicephalussanguineus 

### for up to 4 weeks: Acceptable When used monthly [brand name] completely breaks the flea life cycle and controls tick and chewing lice infestations: Acceptable Kills American Dog Ticks [(Dermacentor variabilis)] 

### for up to 4weeks!: Acceptable Apply once every [4 weeks]!: Acceptable 4 weeks Flea and Tick Treatment: Acceptable Once A Month Flea and Tick Treatment: Acceptable Kills Fleas and Ticks for up to 4 weeks!: Acceptable Kills all stages ofthe flea life cycle: Acceptable Kills fleas, Ticks, Flea Eggs & 

### Flea Larvae for up to 4 Weeks: Acceptable Kills mosquitoes: Acceptable Dogs can bebathed 24 hours after**squeeze~on** 

### is applied: Unacceptable Prevents and controls reinfestations: Unacceptable unless a pest and duration ofcontrol is associated (e.g., 'prevents and controls reinfestations oflisted pests for 1 month [4 weeks]'). BACK/SIDE CARTON LABEL-MASTER LABEL [brandname] containes Fiproni!. and the insect growth regulator (lOR) Nylar® to effectivelykill [and repel] Fleas. Ticks [(including those that may transmit Lyme Disease)]. andkills flea eggs, flea larvae, mosquitoes and (chewing) lice. The active ingredients in [brand name] work by collecting in the hairfollicles and skin oils. This product features a sustained-release formula that discharges from the animal's hairfollicles using the natural skin oils, resulting in fast acting [and long lasting] control ofFleas and Ticks [(in as little as one hour)]. [and kills mosquitoes]

### and chewing lice [for 30 days: All repels claims mustbe removed from the label. The claims about movement inhair follicles is deferred to the RM Reviewer and PM. and chewing lice [for 30 days: All repels claims mustbe removed from the label. The claims about movement inhair follicles is deferred to the RM Reviewer and PM.

# To the Document Center (ITRMD) *Pleasetransferjacket/mini-jacketto the ProductManager Team circled below: 

# Minor Use Section:

Insecticide Branch:

Herbicide Branch:
Fungicide Branch: PM-5

PM-23

PM-20 PM-13

PM-25

PM-21 PM-22



# Insect/Rodent Branch: PM-l PM-7

*Reminderto PM

- Ifapplicable, pick-up data from the Screening Room.
Processed by RD's Completeness Check Team

(Team Member Signature) (Date) 

# To the Document Center (ITRMD) *Pleasetransferjacket/mini-jacketto the ProductManager Team circled below: 

# Minor Use Section: 

# PM-5

Insecticide Branch: 

# PM -10 PM-13

Herbicide Branch: 

# PM-23 PM-25
Fungicide Branch: 

# PM-20 PM-21 PM-22

Insect/Rodent Branch: 

# PM-l PM-7

*Reminderto PM

- Ifapplicable, pick-up data from the Screening Room.
Processed by RD's Completeness Check Team

(Team Member Signature) (Date)

# 21-Day Screen Completed, by Contractor



# - 21-Day Expires on**---,-9_-/~/_o~~_**


# Jacket # d!5l7- Rut( 

# MRID# tf1l gCjcf 

# Content Screen: Recommended to J!as.§VFail 86-5

# ReVieW:EasS~Faned/NA 

# Transfer This Jacketto: 21-Day**Scree~** 

# Completed, by 

# Contractor-

::n
. 

# 21 """Day 

# Expires on -=--==9---='1 -_ 1

# D~~~


# Jacket 

# # 

# d.5/7- RUrf. 

# MRID# tf8'f

# gc;cf 

# Content Screen: Recommended to 

# fa

86-5 

# xeview:[?aSSedfFih 

# Transfer This Jacketto:**~--_. ---~~~~-_.~-----------** **-~---- ---~**  

# Completion of 21-Day Content Screen


# PM- 

# )0
EPA Reg. #(File Symbol)

# /;;2/:;/

# r**~)2VJ(** Decision # 

# D _
Data package delivered to you onr!Zo//o·

. (date) 

# Jacket/Mini-jacket will be transferred to you today. (Pick up from Document Center)



# Thank you, Registration Division's 21-Day Content Team



# Completion of

# 21-Day Content Screen


# PM- 

# /0
EPA Reg. #(File Symbol)

# /:2r;;1 

# r**~)2VJ(** Decision # 

# D

------ Data package delivered to you 

# on "7/20

# //0.

. "", (date) 

# Jacket/Mini-jacket will be transferred to you today. (Pick up from Document Center)



# Thank 

# you, Registration Division's 21-Day Content Team

# Memorandum
Date: 

# 8' / !'J / 

# /0 

# To:

__-----'P---"-"./\,J"-------'--/!.LQ , 

# Regulatory Manager From: Information Services Branch, ITRMD Yourreceipt ofthis data submission is not an indication that MRIDs for the enclosed studies have beenposted to OPPIN. We expect that it will be approximately 5 days from the above date before the study-level data is available in OPPIN. 

# Ifyou have any questions about this process, please contact TeresaDowns (305-5363).

This is a: fully accepted submission 

# n partially accepted submission 

# o rejected submission 

# Memorandum
Date: 

# 8' / !'J / 

# /0 

# To:

__-----'P---"-"./\,J"-------'--/!.LQ , 

# Regulatory Manager From: Information Services Branch, ITRMD Yourreceipt ofthis data submission is not an indication that MRIDs for the enclosed studies have beenposted to OPPIN. We expect that it will be approximately 5 days from the above date before the study-level data is available in OPPIN. 

# Ifyou have any questions about this process, please contact TeresaDowns (305-5363).

This is a: fully accepted submission 

# n partially accepted submission 

# o rejected submissionUNITED STATES ENVIRONMENTAL PROTECTION AG&Y WASHINGTON, D.C. 20460



### August 16,2010 'FICEOF**PREVEN~~,** PESTICIDES AND TO:SUBSTANCES 

### SERGEANT'S PET CARE PRODUCTS, INC. 2625 SOUTH 158TH PLAZA OMAHA, NE 68130-1703
Report ofAnalysis for Compliance with PR Notice 86-5 Thank you for your submittal ofll-AUG-l

## o. Our staffhas completed.Jreliminary analysis ofthe material. The results are provided as follows:
Your submittal was found to be in full compliance with the standards fmbmission of data contained in PR Notice 86-5. A copy ofyourbibliography is enclosed, altated with Master Record ID's (MRIDs) assigned to each document submitted. Please whese numbers in all future references to these documents. Thankyou for your cooperation. If1 

### have any questions concerning this data submission, please raise them with the cognizanroduct Manager, to whom the data have been released. UNITED STATES ENVIRONMENTAL PROTECTION AG&Y WASHINGTON, D.C. 20460



### August 16,2010 'FICEOF**PREVEN~~,** PESTICIDES AND TO:SUBSTANCES 

### SERGEANT'S PET CARE PRODUCTS, INC. 2625 SOUTH 158TH PLAZA OMAHA, NE 68130-1703
Report ofAnalysis for Compliance with PR Notice 86-5 Thank you for your submittal ofll-AUG-l

## o. Our staffhas completed.Jreliminary analysis ofthe material. The results are provided as follows:
Your submittal was found to be in full compliance with the standards fmbmission of data contained in PR Notice 86-5. A copy ofyourbibliography is enclosed, altated with Master Record ID's (MRIDs) assigned to each document submitted. Please whese numbers in all future references to these documents. Thankyou for your cooperation. If1 

### have any questions concerning this data submission, please raise them with the cognizanroduct Manager, to whom the data have been released.

# 3 Fee For Service: 

### r.**ffe·$~** C No 

# 3 BIllable: 

### r. Yes 

### r No Regulatory Type: Jproduct Registration" section 3 Application Type: INew Registration Company;

### ~-**~E'RofANT'S** 

## PET CARE PRODUCTS, INC. IRegistration Division, Risk Management T earn 10 

# ,3 

# ;===

__"1 ProdUct Nfllne:':eERGEANT'S FIPRONIL**NY~AR** SQUEEZE·( Print Letter Enter More lnfonnation



### >

### TRANSMITTAL DOCUMENT NAME AND ADDRESS OF SUBMITTER: Sergeant's Pet CareProducts, Inc. 2625 South 158" Plaza Omaha, NE 68130-1770 

### CONTACT PERSON (Return to) Kelly R. 

### Hoskins Sergeant's Pet Care Products, Inc. 2625 South 158" Plaza Omaha, NE 68130-1770 

### REGULATORY ACTION SUPPORTED BY THIS PACKAGE: This submission is preparedto support an EPAregistration application for the new end-use product Sergeant's Fipronil 

### +Nylar Squeeze-On for Dogs. SUBMITTAL DATE: August 11, 2010



### Volume StudyTitle 

### MRIDNo. 1 

### Administrative Materials 2 

### Group 

### A Product ChemistryFor Sergeant's Fipronil 

### + Nylar 48189401 Saueeze-On For Dogs 3 

### Group 

### B Product ChemistryFor Sergeant's Fipronil 

### +Nylar 48189402 Squeeze-On For Dogs 

### TRANSMITTAL DOCUMENT NAME AND ADDRESS OF SUBMITTER: Sergeant's Pet CareProducts, Inc. 2625 South 158" Plaza Omaha, NE 68130-1770 

### CONTACT PERSON (Return to) Kelly R. 

### Hoskins Sergeant's Pet Care Products, Inc. 2625 South 158" Plaza Omaha, NE 68130-1770 

### REGULATORY ACTION SUPPORTED BY THIS PACKAGE: This submission is preparedto support an EPAregistration application for the new end-use product Sergeant's Fipronil 

### +Nylar Squeeze-On for Dogs. SUBMITTAL DATE: August 11, 2010



### Volume StudyTitle 

### MRIDNo. 1 

### Administrative Materials 2 

### Group 

### A Product ChemistryFor Sergeant's Fipronil 

### + Nylar 48189401 Saueeze-On For Dogs 3 

### Group 

### B Product ChemistryFor Sergeant's Fipronil 

### +Nylar 48189402 Squeeze-On For DogsUN,') STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

September 7, 2010 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES OPP Decision Number: D-438358 EPA File Symbol or Registration Number: 2517-RUR ProductName: SERGEANT'S FIPRONIL 

### +NYLAR SQUEEZE-ON FOR DOGS EPA Application Receipt Date: II-Aug-2010 EPA Waiver Request Receipt Date: ll-Aug-2010 EPA Company Number: 2517 Company Name: SERGEANT'S PET CARE PRODUCTS, INC.
KELLY 

### R HOSKINS SERGEANT'S PET CARE PRODUCTS, INC. 2625 SOUTH 158THPLAZA OMAHA, NE 68130-1703
SUBJECT: Approval of50% Small Business Waiver Request
Dear Registrant: The Office ofPesticide Programs has approved yourrequest for 50% waiver ofthe pesticide registration fee associated with the action referenced above. The decision review period for this action will begin on the date ofthis letter.
The Action has been identified as Action Code: R320
NEW PRODUCT;NON-FAST TRACK;NEW PHYSICAL FORM (EXCLUDES SELECTIVE CITATIONS);
Ifyou have any questions, please contact the Pesticide Registration Service Fee Ombudsman, at (703) 308-9362.
Sincerely,

# jV~~JJ**)~3,\** 

# (j--

Oscar Morales, Director Infonnation Technology & Resources Management Division Office ofPesticide Programs UN,') STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

September 7, 2010 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES OPP Decision Number: D-438358 EPA File Symbol or Registration Number: 2517-RUR ProductName: SERGEANT'S FIPRONIL 

### +NYLAR SQUEEZE-ON FOR DOGS EPA Application Receipt Date: II-Aug-2010 EPA Waiver Request Receipt Date: ll-Aug-2010 EPA Company Number: 2517 Company Name: SERGEANT'S PET CARE PRODUCTS, INC.
KELLY 

### R HOSKINS SERGEANT'S PET CARE PRODUCTS, INC. 2625 SOUTH 158THPLAZA OMAHA, NE 68130-1703
SUBJECT: Approval of50% Small Business Waiver Request
Dear Registrant: The Office ofPesticide Programs has approved yourrequest for 50% waiver ofthe pesticide registration fee associated with the action referenced above. The decision review period for this action will begin on the date ofthis letter.
The Action has been identified as Action Code: R320
NEW PRODUCT;NON-FAST TRACK;NEW PHYSICAL FORM (EXCLUDES SELECTIVE CITATIONS);
Ifyou have any questions, please contact the Pesticide Registration Service Fee Ombudsman, at (703) 308-9362.
Sincerely,

# jV~~JJ**)~3,\** 

# (j--

Oscar Morales, Director Infonnation Technology & Resources Management Division Office ofPesticide Programs

## PRIA 2 - 21 Day Content Screen Review Worksheet (EPAJOPP 

### Use Only) 3/23/09 21 Day Screen StartDate: 

# a- -//

- I' 

### 0 ./ Experts In-Processing Signature: 

## r-r.c /.{.I'1=A,f**I'N~ ;p~**  

### Date 

### 1? 

### -/2 ·/0 

### Fee Paid: Yes**~V** 

### Division manaoernent 

### contacted on issues No Yes Date 0 

### EPA Reg. Number: 

### 2::-0- 

# RUR... EPA Receipt Date: 

# J-- 11-10 

# I Items for Review Ves No N/A*


### 1 Application Form (EPA Form 8570-1 )(link to form) signed & 

### complete 

# , including package type
Confidential Statement ofFormula all boxes completed, form signed, and 

# X dated (EPA Form 8570-4) (Linkto fonn) 2 a) All inerts (link to http://www.epa.gov/opprdOOl/inertsl), yes no including fragrances, approved for the proposed uses (see 

# X Footnote A) 

### 3 

### Certification with Respectto Citation ofData (EPA Fonn**8570~34)** 

### (Linkto 

# X fonn) completed and signed (N/A if 100% repack) Certificate and data matrix consistent 

# XIfapplicantis relying on data that are compensable, is the offer yes no to pay statement included. (see Footnote B)

Ifaoolicable, is there a letter ofAuthorization for exclusive use onlv. Formulator's Exemption Statement (EPA Form 8570-27) (Linkto form) 

# )c 4 completed and signed (N/A ifsource is unregistered or applicant owns the technical)
Data Matrix (EPA Form 8570-35) (Link to form) hath internal and external 

# >< copies (PR 98-5) (Link to PR 98-5) completed and signed (N/A if 100% renack) 5 yes no a) Selective Method (Fee category experts use) 

## K

h) Cite-All (Fee category experts use) c) Applicant owns all data (Fee category experts use)
5 Copies ofLabel (linkto http://www.epa.gov/oppfeadlllabeling/lrmD 

# )( 6 (Electronic labels on CD are encouraged and guidance is available)( link to hUp:l!www.epa.gov/pesticjdes/regulating/registering/submissions/index.htm#labels )



### 1 

## PRIA 2 - 21 Day Content Screen Review Worksheet (EPAJOPP 

### Use Only) 3/23/09 21 Day Screen StartDate: 

# a- -// - I' 

### 0 ./ Experts In-Processing Signature: 

## r-r.c /.{.I'1=A,f**I'N~ ;p~**  

### Date 

### 1? -/2 ·/0 

### Fee Paid: Yes**~V** 

### Division manaoernent 

### contacted on issues No Yes Date 0


### EPA Reg. Number: 

## 2::-0- 

# RUR... EPA Receipt Date: 

# J-- 11-10 

# I Items for Review Ves No N/A*


### 1 Application Form (EPA Form 8570-1 )(link to form) signed & 

### complete 

# , including package type
Confidential Statement ofFormula all boxes completed, form signed, and 

# X dated (EPA Form 8570-4) (Linkto fonn) 2 a) All inerts (link to http://www.epa.gov/opprdOOl/inertsl), yes no including fragrances, approved for the proposed uses (see 

# X Footnote A) 

### 3 

### Certification with Respectto Citation ofData (EPA Fonn**8570~34)** 

### (Linkto 

# X fonn) completed and signed (N/A if 100% repack) Certificate and data matrix consistent 

# XIfapplicantis relying on data that are compensable, is the offer yes no to pay statement included. (see Footnote B)

Ifaoolicable, is there a letter ofAuthorization for exclusive use onlv. Formulator's Exemption Statement (EPA Form 8570-27) (Linkto form) 

# )c 4 completed and signed (N/A ifsource is unregistered or applicant owns the technical)
Data Matrix (EPA Form 8570-35) (Link to form) hath internal and external 

# >< copies (PR 98-5) (Link to PR 98-5) completed and signed (N/A if 100% renack) 5 yes no a) Selective Method (Fee category experts use) 

## K

h) Cite-All (Fee category experts use) c) Applicant owns all data (Fee category experts use)
5 Copies ofLabel (linkto http://www.epa.gov/oppfeadlllabeling/lrmD 

# )( 6 (Electronic labels on CD are encouraged and guidance is available)( link to hUp:l!www.epa.gov/pesticjdes/regulating/registering/submissions/index.htm#labels )



### 1

### 7 Is the data package consistentwith PRNotice 86-5 (linkto PRJ'\! 86-5) 

# X

Notice ofFiling (link to 8 

### http://www.epa.govfpesticides/regulatingltolerance petitions.htm) incl

### udcd with petitions (link to 

# K http://www.eva.2ov/vesticideslregulating/tolerances.htm) 

# , , 9 

### If

### applicable for conventional applications, reduced risk rationale (linkto 

# X http://www.epa.gov/opprdOOllworkplan/reducedrisk.html) Required Data (linkto http://\vww.epa.gov/pesticides/regulating/data requirements.htm) and/or data waivers. See Footnote C.

a) List study (or studies) not included with application



### 10



# ,

2 7 Is the data package consistentwith PRNotice 86-5 (linkto PRJ'\! 86-5) 

# X

Notice ofFiling (link to 8 

### http://www.epa.govfpesticides/regulatingltolerance petitions.htm) incl

### udcd with petitions (link to 

# K http://www.eva.2ov/vesticides/regulating/tolerances.htm) 

# , , 9 

### If

### applicable for conventional applications, reduced risk rationale (linkto 

# X http://www.epa.gov/opprdOOllworkplan/reducedrisk.html) Required Data (linkto http://\vww.epa.gov/pesticides/regulating/data requirements.htm) and/or data waivers. See Footnote C.

a) List study (or studies) not included with application



### 10



# ,

2

### Comments:



## *N/A

- 

### Not Applicable

Footnotes A. 

### During the 21 day initial contentreview, all eSFs will be reviewed to determine whether all inerts listed, including fragrances, are approved for the proposeduses. Ifan unapproved inert is identified, the applicant must either 1) resolve the inert issue by, for example, removing the inert, substituting it with an approved inert, submitting documentation thatEPA approvedthe inert for the proposedpesticidal uses, correcting mistakes on the eSF, etc. or 2) provide the data to support OPP approval ofthe inert or 3) withdraw the application. Removing or substituting an inertingredient will require a new eSF and may require submission ofdata. All infonuation, fonus, data and documentation resolving the inert issue musthave been receivedby the Agency or the application withdrawn within the 21 day period. othenvise, the Agencv will reject the application as described below. To successfully complete this aspect ofthe 21 day initial content screen, applicants are strongly encouraged to verify that all inert ingredients have been approved for the application's uses even ifa product is currently registered by consulting the inert Web 

### 3 Comments:

j 0. .r-... 

### Ii\C I 

### h QC\J r-:}YD 

### \.Dr ('ont»)C\ U}, L 1



## *N/A

- 

### Not Applicable

Footnotes A. 

### During the 21 day initial contentreview, all eSFs will be reviewed to determine whether all inerts listed, including fragrances, are approved for the proposeduses. Ifan unapproved inert is identified, the applicant must either 1) resolve the inert issue by, for example, removing the inert, substituting it with an approved inert, submitting documentation thatEPA approvedthe inert for the proposedpesticidal uses, correcting mistakes on the eSF, etc. or 2) provide the data to support OPP approval ofthe inert or 3) withdraw the application. Removing or substituting an inertingredient will require a new eSF and may require submission ofdata. All information, forms, data and documentation resolving the inert issue musthave been receivedby the Agency or the application withdrawn within the 21 day period. otherwise, the Agencv will reject the application as described below. To successfully complete this aspect ofthe 21 day initial content screen, applicants are strongly encouraged to verify that all inert ingredients have been approved for the application's uses even ifa product 

### is currently registered by consulting the inert Web 

### 3

### site [link to http://www.epa.gov/opprdOOI/inelts/lists.htrnl] and ifthe inert is not approved, to obtain the necessary inert approval prior to submitting an application to register a pesticide product containing that inert ingredient. Some inelt ingredients are no longer approved for food uses or certaintypes ofuses. The name and/or CAS number on a CSF must match the name and CAS number onthis web site. Simple typographical errors in the name or CAS number have resulted inprocessing delays. Ifan inert is not listed onthe inert ingredient web site andthe applicant believes thatthe inert has been approved, the applicant should contactthe InertIngredient Assessment Branch (nAB) at inertsbranch@epa.gov and resolve the issue. Copies ofthe correspondence with nAB resolving the issue should accompany the application. All new inerts except PIP inerts are reviewed by nAB. The IIAB should also be contacted for any questions on what supporting dataneeds to be submitted for and the Agency's inert review process. Questions on PIP inerts shouldbe directed to the Chiefof Microbial Pesticides Branch [Linkto http://www.epa.gov/oppbppdl/biopesticides/contactsbppd.htm]. 'When a brand, trade, orproprietary name ofan inert ingredientis listed on a CSP, additional information such as an alternate name ofthe inert, CAS number or other information [linkto http://www.epa.gov/opprdOOllinerts/tips.pdfJ must also be included to enable the Agency to detennine ifit has been approved. Each component ofan inert mixture (including a fragrance) must be identified. In some cases, the supplier ofthe mixture or fragrance may need to provide this infonnation to the Agency. Priorto the Agency's receipt ofan application, applicants must arrange with a proprietary mixture or fragrance supplier to provide the component information to the Agency or promptly upon EPA's request. Ifthe inert ingredients in aproprietary blend (including fragrances) cannot or are not identified orprovided within the 21-day contentreview period, the Agency will reject the application. During the 21 day contentreview, applicants should submit infonnation to the individual identified by the Agency when the applicant is infonned ofan unapproved inert. Unapproved Joerts Identified on CSFs All applications except conventional new products andPIPs Once an unapproved inert is identified on a CSF, the Agency will contact the applicantwiththe following options: 1. Correct the application by, for instance, correcting the inert's identity or CAS number, providing documentation that the inerthas been approved, or removing the unapproved inert from the CSF orreplacing itwith one that is approved for the application's uses; or 2. Submit the information and data needed for the Agency to approve the unapproved inert. Ifthis option is selected and implemented, the Agency may request an extension in the PRIA decision review timeframe to accommodate the inertreview/approval process; 4 

### site [link to http://www.epa.gov/opprdOOI/inelts/lists.htrnl] and ifthe inert is not approved, to obtain the necessary inert approval prior to submitting an application to register a pesticide product containing that inert ingredient. Some inelt ingredients are no longer approved for food uses or certaintypes ofuses. The name and/or CAS number on a CSF must match the name and CAS number onthis web site. Simple typographical errors in the name or CAS number have resulted inprocessing delays. Ifan inert is not listed onthe inert ingredient web site andthe applicant believes thatthe inert has been approved, the applicant should contactthe InertIngredient Assessment Branch (nAB) at inertsbranch@epa.gov and resolve the issue. Copies ofthe correspondence with nAB resolving the issue should accompany the application. All new inerts except PIP inerts are reviewed by nAB. The IIAB should also be contacted for any questions on what supporting dataneeds to be submitted for and the Agency's inert review process. Questions on PIP inerts shouldbe directed to the Chiefof Microbial Pesticides Branch [Linkto http://www.epa.gov/oppbppdl/biopesticides/contactsbppd.htm]. 'When a brand, trade, orproprietary name ofan inert ingredientis listed on a CSP, additional information such as an alternate name ofthe inert, CAS number or other information [linkto http://www.epa.gov/opprdOO1/inerts/tips.pdfJ must also be included to enable the Agency to detennine ifit has been approved. Each component ofan inert mixture (including a fragrance) must be identified. In some cases, the supplier ofthe mixture or fragrance may need to provide this infonnation to the Agency. Priorto the Agency's receipt ofan application, applicants must arrange with a proprietary mixture or fragrance supplier to provide the component information to the Agency or promptly upon EPA's request. Ifthe inert ingredients in aproprietary blend (including fragrances) cannot or are not identified orprovided within the 21-day contentreview period, the Agency will reject the application. During the 21 day contentreview, applicants should submit infonnation to the individual identified by the Agency when the applicant is infonned ofan unapproved inert. Unapproved Joerts Identified on CSFs All applications except conventional new products andPIPs Once an unapproved inert is identified on a CSF, the Agency will contact the applicantwith the following options: 1. Correct the application by, for instance, correcting the inert's identity or CAS number, providing documentation that the inerthas been approved, or removing the unapproved inert from the CSF orreplacing itwith one that is approved for the application's uses; or 2. Submit the information and data needed for the Agency to approve the unapproved inert. Ifthis option is selected and implemented, the Agency may request an extension in the PRIA decision review timeframe to accommodate the inertreview/approval process; 4

### 3. Withdraw the application (the Agency retains 25% ofthe full fee for the fee category estimated); or Ifnone ofthese options is selected and implemented by the applicant within the 21 day content review period, the Agency will rejectthe application and retain 25% ofthe full fee ofthe category identified. Conventional New Product Applications When the Registration Division identifies an unapproved inert on a CSF with an application for a new product that the applicant has not identified as requiring an inert approval (R3ll, R312 or R313), it will contactthe applicantwith the following options: 1. Correct the application by, for instance, correcting the inert's identity or CAS number, providing documentation that the inert has been approved, or removing the unapproved inert from the CSF or replacing itwith one thatis approved for the application's uses; or 2. Submit the information and data needed for the Agency to approve the unapproved inert, including any required petitionto establish or amend a tolerance or exemption from a tolerance. (This option may change the PRIA category for the application, which could require a longer decision review time and a larger fee. Ifadditional fees are due, they must be received by the Agency within the 21 day content review period.) 3. Withdraw the application (the Agency retains 25% ofthe full fee for the fee category estimated); or

Ifnone ofthe above options is selected and implemented during the 21-day content-review period, the Agency will reject the application and retain 25% of the appropriate fee for the new product-inert approval category. PIP Applications When the Biopesticide and PollutionPrevention Division identifies an unapproved inert on aPIP CSF and a request to approve the inert does not accompany the application, it will contact the applicant with the following options: 1. Correctthe application by, for instance, correcting the spelling or name ofthe inert to that in 40 CFR 174, or providing documentation that the inert has been approved; or 2. Submit the information and data needed for the Agency to approve the unapproved inert. Ifan inert ingredient tolerance exemptionpetition is required, the petition must be received by the Agency and the B903 fee paid within the 21 day period. Ifthis option is selected and implemented, the Agency will discuss harmonizing the timeframe for both actions. 5 3. Withdraw the application (the Agency retains 25% ofthe full fee for the fee category estimated); or Ifnone ofthese options is selected and implemented by the applicant within the 21 day content review period, the Agency will rejectthe application and retain 25% ofthe full fee ofthe category identified. Conventional New Product Applications When the Registration Division identifies an unapproved inert on a CSF with an application for a new product that the applicant has not identified as requiring an inert approval (R3ll, R312 or R313), it will contactthe applicantwith the following options: 1. Correct the application by, for instance, correcting the inert's identity or CAS number, providing documentation that the inert has been approved, or removing the unapproved inert from the CSF or replacing itwith one thatis approved for the application's uses; or 2. Submit the information and data needed for the Agency to approve the unapproved inert, including any required petitionto establish or amend a tolerance or exemption from a tolerance. (This option may change the PRIA category for the application, which could require a longer decision review time and a larger fee. Ifadditional fees are due, they must be received by the Agency within the 21 day content review period.) 3. Withdraw the application (the Agency retains 25% ofthe full fee for the fee category estimated); or

Ifnone ofthe above options is selected and implemented during the 21-day content-review period, the Agency will reject the application and retain 25% of the appropriate fee for the new product-inert approval category. PIP Applications When the Biopesticide and PollutionPrevention Division identifies an unapproved inert on aPIP CSF and a request to approve the inert does not accompany the application, it will contact the applicant with the following options: 1. Correctthe application by, for instance, correcting the spelling or name ofthe inert to that in 40 CFR 174, or providing documentation that the inert has been approved; or 2. Submit the information and data needed for the Agency to approve the unapproved inert. Ifan inert ingredient tolerance exemptionpetition is required, the petition must be received by the Agency and the B903 fee paid within the 21 day period. Ifthis option is selected and implemented, the Agency will discuss harmonizing the timeframe for both actions. 5

### 3. Withdraw the application (the Agency retains 25% ofthe 

### full fee for the fee category estimated); or Ifnone ofthe above options is selected and implemented during the 21 day content review period, the Agency will reject the application and retain 25% of the fee.

B. A policy on documentation ofoffers to pay is still being developed, however, for a me-too or fast track (similar/identical) new product, R300 or A530, an application withoutthe necessary authorizations ofoffers to pay will be placed into either R301 or A53!. The Agency recommends that authorizations ofoffers to pay be submitted with other PRlA 

### applications to avoid delays in the Agency's decision. C. Biopesticide applicants are advised to contact the Agency and discuss study waivers prior to submitting their application to the Agency. Documentation ofsuch discussions should be submitted with the study waiver.

6 3. Withdraw the application (the Agency retains 25% ofthe 

### full fee for the fee category estimated); or Ifnone ofthe above options is selected and implemented during the 21 day content review period, the Agency will reject the application and retain 25% of the fee.

B. A policy on documentation ofoffers to pay is still being developed, however, for a me-too or fast track (similar/identical) new product, R300 or A530, an application withoutthe necessary authorizations ofoffers to pay will be placed into either R301 or A53!. The Agency recommends that authorizations ofoffers to pay be submitted with other PRlA 

### applications to avoid delays in the Agency's decision. C. Biopesticide applicants are advised to contact the Agency and discuss study waivers prior to submitting their application to the Agency. Documentation ofsuch discussions should be submitted with the study waiver.

6UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

October4, 2010 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES OPP Decision Number: D·438358 EPA File Symbol or Registration Number: 2517-RUR ProductName: SERGEANT'S FIPRONIL 

### +NYLAR SQUEEZE·ON FORDOGS EPA Receipt Date: 11·Aug·2010 EPA Company Number: 2517 Company Name: SERGEANT'S PET CARE PRODUCTS, INC.
KELLY R. HOSKINS SERGEANT'S PET CARE PRODUCTS, INC. 2625 SOUTH 158TH PLAZA OMAHA, NE 68130·1703

SUBJECT: Receipt ofRegistration Application Subject to Registration Service Fee
DearRegistrant:
The Office ofPesticide Programs has received your application and certification of payment. Ifyou submitted data with this application, the results ofthe PRN-86-5 screen will be communicated separately. During the administrative screen, the Office ofPesticide Programs has detennined that this Action is subjectto a Pesticide Registration Service Fee as defined in the Pesticide Registration Improvement Act.
The Action previously identified as R320 has been reclassified as as Action Code: R31 0
NEW PRODUCT;NON·FAST TRACK (INCLUDES REVIEWS OF PRODUCT CHEMISTRY;ACUTE TOX1C1TY;PUBLIC HEALTH PEST EFFICACY);

The fee associated "Withthis aciton is $ 2,289 (50% of$ 4,578). Payment ifthe amount of $ 5,712 has been received. A refund in the amount of$ 3,423 "Will be issued as soon as the action is completed.
Ifyou have any questions, please contactthe Pesticide Registration Service Fee Ombudsman at (703) 308·9362. Sincerely, Front End Processing Staf Infonnation Technolo & UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

October4, 2010 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES OPP Decision Number: D·438358 EPA File Symbol or Registration Number: 2517-RUR ProductName: SERGEANT'S FIPRONIL 

### +NYLAR SQUEEZE·ON FORDOGS EPA Receipt Date: 11·Aug·2010 EPA Company Number: 2517 Company Name: SERGEANT'S PET CARE PRODUCTS, INC.
KELLY R. HOSKINS SERGEANT'S PET CARE PRODUCTS, INC. 2625 SOUTH 158TH PLAZA OMAHA, NE 68130·1703

SUBJECT: Receipt ofRegistration Application Subject to Registration Service Fee
DearRegistrant:
The Office ofPesticide Programs has received your application and certification of payment. Ifyou submitted data with this application, the results ofthe PRN-86-5 screen will be communicated separately. During the administrative screen, the Office ofPesticide Programs has detennined that this Action is subjectto a Pesticide Registration Service Fee as defined in the Pesticide Registration Improvement Act.
The Action previously identified as R320 has been reclassified as as Action Code: R31 0
NEW PRODUCT;NON·FAST TRACK (INCLUDES REVIEWS OF PRODUCT CHEMISTRY;ACUTE TOX1C1TY;PUBLIC HEALTH PEST EFFICACY);

The fee associated "Withthis aciton is $ 2,289 (50% of$ 4,578). Payment ifthe amount of $ 5,712 has been received. A refund in the amount of$ 3,423 "Will be issued as soon as the action is completed.
Ifyou have any questions, please contactthe Pesticide Registration Service Fee Ombudsman at (703) 308·9362. Sincerely, Front End Processing Staf Infonnation Technolo &UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

September 1,2010 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUESTANCES PLEASE RETURN A COPY OF THIS LETTER WIlli PAYMENT OrPay OnMLine at\VWW.Pay.Gov (See Below for Details)
OPP Decision Number: D-438358 EPA File Symbol orRegistration Number: 2517-RUR ProductName: SERGEANT'S FIPRONIL 

### + NYLAR SQUEEZE-ON FOR DOGS EPA Receipt Date: II-Aug-2010 EPA Company Number: 2517 Company Name: SERGEANT'S PET CARE PRODUCTS, INC.
KELLY R. HOSKINS SERGEANT'S PET CARE PRODUCTS, INC. SERGEANT'S PET CARE PRODUCTS, INC. 2625 SOUlli 158TH PLAZA OMAHA, NE 68130-1703

SUBJECT: Receipt ofRegistration Application Subject to Registration Service Fee
DearRegistrant
The Office ofPesticide Programs has received your application for registration. Ifyou submitted data with this application, the results ofthe PRN-86-S screen will be communicated separately. During the administrative screen, the Office ofPesticide Programs has detennined that this Action is subject to a Pesticide Registration Service Fee as defmed in the Pesticide Registration Improvement Act.
The Action previously identified as R3l0 has been reclassified as Action Code: R320
NEW PRODUCT;NON-FAST TRACK;NEW PHYSICAL FORM (EXCLUDES SELECTIVE CITATIONS);
The fee associated with this action is $ 5,712 (50% of $ 11,424). Payment in the amount of $2,289 has been received. Please remit additional payment in the amount of$ 3,423 to: ByUSPS:

USEPA Washington Finance Center Pesticide Registration Service Fee PO Box 979074 St. Louis, MO 63197-9000 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

September 1,2010 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUESTANCES PLEASE RETURN A COPY OF THIS LETTER WIlli PAYMENT OrPay OnMLine at\VWW.Pay.Gov (See Below for Details)
OPP Decision Number: D-438358 EPA File Symbol orRegistration Number: 2517-RUR ProductName: SERGEANT'S FIPRONIL 

### + NYLAR SQUEEZE-ON FOR DOGS EPA Receipt Date: II-Aug-2010 EPA Company Number: 2517 Company Name: SERGEANT'S PET CARE PRODUCTS, INC.
KELLY R. HOSKINS SERGEANT'S PET CARE PRODUCTS, INC. SERGEANT'S PET CARE PRODUCTS, INC. 2625 SOUlli 158TH PLAZA OMAHA, NE 68130-1703

SUBJECT: Receipt ofRegistration Application Subject to Registration Service Fee
DearRegistrant
The Office ofPesticide Programs has received your application for registration. Ifyou submitted data with this application, the results ofthe PRN-86-S screen will be communicated separately. During the administrative screen, the Office ofPesticide Programs has detennined that this Action is subject to a Pesticide Registration Service Fee as defmed in the Pesticide Registration Improvement Act.
The Action previously identified as R3l0 has been reclassified as Action Code: R320
NEW PRODUCT;NON-FAST TRACK;NEW PHYSICAL FORM (EXCLUDES SELECTIVE CITATIONS);
The fee associated with this action is $ 5,712 (50% of $ 11,424). Payment in the amount of $2,289 has been received. Please remit additional payment in the amount of$ 3,423 to: ByUSPS:

USEPA Washington Finance Center Pesticide Registration Service Fee PO Box 979074 St. Louis, MO 63197-9000

### By Courier: U.S. Bank Government Lockbox 979074 1005 Convention Plaza SL-MO-C2-GL St. Louis. MO 63197 Telephone: (412) 236-2294
All payments mustbe in United States currency by check, bank draft, ormoney order dra\¥Il to the order ofthe Environmental Protection Agency. To ensure proper credit, please write the OPP DECISION NUMBER on your check, and enclose a copy ofthis letter with your payment. Effective November 1, 2006, fees may be paid on-line via credit card or electronic fund transfer. To submit a payment on-line, visit www.pay.gov. From the pay.gov home page, select "search by fonn name." From the next page, select "P," then click on "Pesticide Registration ImprovementAct. Fee Payment" and complete the fonn, making certainto use the decision number and registration number on the invoice you receive from the Pesticide Program in the space provided.
You may be eligible for a partial waiver ofthe registration service fee if, for example, you qualify as a small business or are applying for a minor use, or ifyour application is solely associated with an IRA tolerance petition. Please be advised that ifyou intend to request a waiver, you must do so in writing within 15 days ofreceipt ofthis invoice instead ofremitting the amount indicated above. OPP will not considerwaiverrequests afterthe registration service fee has beenpaid. Infonnation regarding eligibility and how th request and document a fee waiver is available on the OPP Fee for Service web site at www.epa.gov/pesticides/fees. Please send Registration Service Fee Waiverrequests to: By USPS: DocumentProcessing Desk (WAIVER) Office ofPesticide Programs (7504C) U.S. Environmental Protection Agency 1200 Pennsylvania Ave NW Washington. DC 20460 By Courier: Document Processing Desk (WAIVER) Office ofPesticide Programs (7504C) U.S. Environmental Protection Agency Room S4900 Potomac Yard 1 2777 S. Crystal Dr. Arlington. VA 22202 By Courier:

U.S. Bank Government Lockbox 979074 1005 Convention Plaza SL-MO-C2-GL St. Louis. MO 63197 Telephone: (412) 236-2294
All payments mustbe in United States currency by check, bank draft, ormoney order dra\¥Il to the order ofthe Environmental Protection Agency. To ensure proper credit, please write the OPP DECISION NUMBER on your check, and enclose a copy ofthis letter with your payment. Effective November 1, 2006, fees may be paid on-line via credit card or electronic fund transfer. To submit a payment on-line, visit www.pay.gov. From the pay.gov home page, select "search by fonn name." From the next page, select "P," then click on "Pesticide Registration ImprovementAct. Fee Payment" and complete the fonn, making certainto use the decision number and registration number on the invoice you receive from the Pesticide Program in the space provided.
You may be eligible for a partial waiver ofthe registration service fee if, for example, you qualify as a small business or are applying for a minor use, or ifyour application is solely associated with an IRA tolerance petition. Please be advised that ifyou intend to request a waiver, you must do so in writing within 15 days ofreceipt ofthis invoice instead ofremitting the amount indicated above. OPP will not considerwaiverrequests afterthe registration service fee has beenpaid. Infonnation regarding eligibility and how th request and document a fee waiver is available on the OPP Fee for Service web site at www.epa.gov/pesticides/fees. Please send Registration Service Fee Waiverrequests to: By USPS: DocumentProcessing Desk (WAIVER) Office ofPesticide Programs (7504C) U.S. Environmental Protection Agency 1200 Pennsylvania Ave NW Washington. DC 20460 By Courier: Document Processing Desk (WAIVER) Office ofPesticide Programs (7504C) U.S. Environmental Protection Agency Room S4900 Potomac Yard 1 2777 S. Crystal Dr. Arlington. VA 22202A PRIA decision time review period will not start until a fee waiver is granted and/or the Agency receives certificationthatthe outstanding fee has been paid. Ifthe Agency does not receive certification ofpayment for this action or a fee waiver request within the next 30 days, the Agency will presume that you no longer wantto pursue this action. The Agency will then reject your application and issue an invoice for any applicable outstanding fees.
Ifyou have any questions, please contactthe Pesticide Registration Service Fee Ombudsman at (703) 308-9362. Sincerely,

esources Management Division 

### A PRIA decision time review period will not start until a fee waiver is granted and/or the Agency receives certificationthatthe outstanding fee has been paid. Ifthe Agency does not receive certification ofpayment for this action or a fee waiver request within the next 30 days, the Agency will presume thatyou no longer wantto pursue this action. The Agency will then reject your application and issue an invoice for any applicable outstanding fees. Ifyou have any questions, please contactthe Pesticide Registration Service Fee Ombudsman at (703) 308-9362. Sincerely,

esources Management Division,-,r.d,C**~:'lrt** €1"" lj**~,t[,:l'-:>,~ "'~''':,**  Cirt;! o! F'II'C,ClI**~I(,,,** .""1 [n[-:>,rr,j['Or "tIOUt:., 

### j",**~.ry<n** :'''·'I'Or, Ir.lOIfT\j [to"**::'r.r~'':H** e,**'''';~-** 

## , 

# 8EPA

**Pl\1:** 10**C:r=S~ylICiu.** 

# No.:

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Thejacket for 

# this action can be 

# requested through the J_ACKETS system.**Ur'~[fC ~:.ltl** **€""I""I'~"('(** 

# l.**~jt[f:lIO,'" t..~.rl:.,.**  Cir,;! o! FI 11,:;,01**~I·i."** .""1 L

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# system.UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



### August 12,2010 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES 

### OPP Decision Number: D-438358 

### EPA File Symbol or Registration Number:**2517~RUR** 

### ProductName: SERGEANT'S FIPRONIL 

### +NYLAR SQUEEZE-ON FOR DOGS EPA Receipt Date: ll-Aug-20 10 EPA Company Number: 2517 Company Name: SERGEANT'S PET CARE PRODUCTS, INC.EPA File Symbol or 

### Registration Number:
KELLY R. HOSKINS SERGEANT'S PET CARE PRODUCTS, INC. 2625 SOUTH 158TH PLAZA OMAHA, NE 68130-1703
SUBJECT: Receipt ofApplication and 50% Small Business Waiver Request 

### DearRegistrant: The Office ofPesticide Programs has received your application, 50% small business waiver request, and cerification ofpayment. If

### you 

### submitted data with this application, the results ofthe 

### PRN-86-5 screen will be communicated separately. During the administrative screen, the Office ofPesticide 

### Programs has determined that this Action is subjectto aPesticide Registration Service Fee as defined in the Pesticide Registration Improvement Act. The Action has been identified as Action Code: R31 0 NEW PRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT CHEMISTRY;ACUTE TOXIClTY;PUBLIC HEALTH PEST EFFICACY);


### Your request for waiver has been forwarded for review. You will be notified in vvriting when a determination is made regarding your request. Ifyour waiver request is approved, the decision reviewtime period will start on the date ofapprovaL Ifyour waiver request is denied, you will receive an invoice for the outstanding balance.
Ifyou 

### have any questions, please contact the Pesticide Registration Service Fee Ombudsman at (703) 308-9362.**S~erely,** 

## \'1 

# IVI..e./.JLl D"h<J"nxL.. Front End Processing Staff Infonnation Technology & 

### Resources Management Division UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



### August 12,2010 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES 

### OPP Decision Number: D-438358 

### EPA File Symbol or Registration Number:**2517~RUR** 

### ProductName: SERGEANT'S FIPRONIL 

### +NYLAR SQUEEZE-ON FOR DOGS EPA Receipt Date: ll-Aug-20 10 EPA Company Number: 2517 Company Name: SERGEANT'S PET CARE PRODUCTS, INC.EPA File Symbol or 

### Registration Number:
KELLY R. HOSKINS SERGEANT'S PET CARE PRODUCTS, INC. 2625 SOUTH 158TH PLAZA OMAHA, NE 68130-1703
SUBJECT: Receipt ofApplication and 50% Small Business Waiver Request 

### DearRegistrant: The Office ofPesticide Programs has received your application, 50% small business waiver request, and cerification ofpayment. If

### you 

### submitted data with this application, the results ofthe 

### PRN-86-5 screen will be communicated separately. During the administrative screen, the Office ofPesticide 

### Programs has determined that this Action is subjectto aPesticide Registration Service Fee as defined in the Pesticide Registration Improvement Act. The Action has been identified as Action Code: R31 0 NEW PRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT CHEMISTRY;ACUTE TOXIClTY;PUBLIC HEALTH PEST EFFICACY);


### Your request for waiver has been forwarded for review. You will be notified in vvriting when a determination is made regarding your request. Ifyour waiver request is approved, the decision reviewtime period will start on the date ofapprovaL Ifyour waiver request is denied, you will receive an invoice for the outstanding balance.
Ifyou 

### have any questions, please contact the Pesticide Registration Service Fee Ombudsman at (703) 308-9362.**S~erely,** 

## \'1 

# IVI..e./.JLl D"h<J"nxL.. Front End Processing Staff Infonnation Technology & 

### Resources Management Division

# IFee for Servicel**~-------- -~~-~-----**  

# (8801811-

This package includes the following

@ 

# New Registration °Amendment

>l] 

# Studies? j{j 

# Fee Waiver? v [J

# volpay 

# % Reduction: 50 for Division 

# °AD °BPPD @RD Risk Mgr. 

# [JQJ**~:::=::::::-** 

# -=-=-:::=::::::- -=--_:_-=---= -:----------------**---;::-~**

# :::=:::::::::=::::::=---=-**--~-~---~----~--~~-** 

# Receipt No.

# S-I=8~8~O~18~1= EPA File Symbol/Reg. No. I 

# 2517-RUR Pin-Punch Date: I 

# 8/11/2010

-'**--~-~--~-~-----------** 

### ____**~J**



## [J 

# This item is NOT subject to FFS action.**~---~----**

### r---~--Action-etyde: 

# Parent/Child Decisions: I : Requested: 

# I j'<,3J 0 

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## Granted: 

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# LAm:~nt Due: 

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## 57&'
Inert Cleared for Intended Use [J 

## Uncleared Inert in Product Reviewer:.

__ 

# --"-'vY'I-.JL (fYI=--'-oA.6L-----=-

_ 

### Remarks: 

## Date: 8/1;>"/10 

# IFee for Servicel**~-------- -~~-~-----**  

# (8801811-

This package includes the following

@ 

# New Registration °Amendment

>l] 

# Studies? j{j 

# Fee Waiver? v [J

# volpay 

# % Reduction: 50 for Division 

# °AD °BPPD @RD Risk Mgr. 

# [JQJ**~:::=::::::-** 

# -=-=-:::=::::::- -=--_:_-=---= -:----------------**---;::-~**

# :::=:::::::::=::::::=---=-**--~-~---~----~--~~-** 

# Receipt No.

# S-I=8~8~O~18~1= EPA File Symbol/Reg. No. I 

# 2517-RUR Pin-Punch Date: I 

# 8/11/2010

-'**--~-~--~-~-----------** 

### ____**~J**



## [J 

# This item is NOT subject to FFS action.**~---~----**

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# Parent/Child Decisions: I : Requested: 

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# --"-'vY'I-.JL (fYI=--'-oA.6L-----=-

_ 

### Remarks: 

## Date: 8/1;>"/10Tracking 

## -.-J" Print letter Enter More Information 

### r- No Yes (' No

j ERGEANT'S PET CARE PROOUC jRegistration Division, Risk'Management'Team 10 duct Name:

### kl'E~~R~G~EA·N~T~'S"~F""~;;'O~N~L"~+;:NY~;;L·A~R·S~Q"lJff·~Z~E;-:-( RegUlatory Type: 'product RegistratIOn: Section 3 Application Type: !NeW,Registration

# FEE 

# FOR SERVICEPay.gov Online Payment Page 1 of 1

Online Payment Step 3: Confirm Payment Thank you. Your transaction has been successfully completed. 11213

Payment Date: 06/2112010 Decision Number: Registration Number: 2517-new Company Name: Sergeant's Pet Care Produ Company Number: 2517 Action Code: R310 Pay.gov Tracking Information Application Name: PRIA Service Fees Pay.gov Tracking 10: 25101L1D Agency Tracking 10: 74122352206 Transaction Date and Time: 06/18/2010 14:33 EDT Payment Summary Account HolderSergeant's Pet Care Products, Name: Inc Payment Amount: $2,289.00 Account Type: Business Checking Routing Number: Account Number:

......5483

httos:/lwww.oav.gov/pavgov/oavments/authorizeACHPavrnent.htmI 6118/2010 Pay.gov Online Payment Page 1 of 1

Online Payment Step 3: Confirm Payment Thank you. Your transaction has been successfully completed. 11213

Payment Date: 06/2112010 Decision Number: Registration Number: 2517-new Company Name: Sergeant's Pet Care Produ Company Number: 2517 Action Code: R310 Pay.gov Tracking Information Application Name: PRIA Service Fees Pay.gov Tracking 10: 25101L1D Agency Tracking 10: 74122352206 Transaction Date and Time: 06/18/2010 14:33 EDT Payment Summary Account HolderSergeant's Pet Care Products, Name: Inc Payment Amount: $2,289.00 Account Type: Business Checking Routing Number: Account Number:

......5483

httos:/lwww.oav.gov/pavgov/oavments/authorizeACHPavrnent.htmI 6118/2010Form Approve JMB No 20700060 Approval expires 05-31 98 Please rerrdInstructfons on reverse before \. Ip/etfng fonn -, 

### - - United States 1l;1Registration OPP Identifier Number 

# EPA Environmental Protection Agency D_Amendment Washington, DC 20460 

# o Other Application for Pesticide - Section I 1. Company/Product NumbeR 2. EPA Product Manager 3. Proposed Classification 2517-NEW 

### R U Richard Gebken 4. Company/ProdUct (Name) 5.PM# 10 L8JNone DRestricted Sergeant's Pet Care Products, Inc. / Sergeants Fipronil + NylarSqueezeOn For DOQS 5, Name and Address ofApplicant (/nclude ZIP Code) 6. Expedited Review. In accordance with AFRA Section 3(c)(3)(b)(I), my Sergeant's Pet Care Products, Inc. product is similar or identical in composition and labeling to: 2625 South 158\11 Plaza Omaha, NE 68130-1770 EPA Reg. No. Product Name 

# o Check ifthis is a new address Section II 

# o Amendment

- Explain below. 

# D Final printed labels in response to Agency letter dated XX-XX-XX 

# o Resubmission in response to Agency letter dated XX-XX-XX 

# o "Me Too" Application 

# o Notification

- Explain below. other

- Explain below. Explanation: Use additional page(s) if necessary. (For section I and Section 11.) Submissior. of a new end-use registration application.
Section III 1. Material This Product Will Be Packaqed In: Child-Resistant Packaging Unit Packaging WaterSoluble Packaging 2 Type of Container 

# o Yes'**~Yes** DYes D Metal DNo D No 

## l:8J No [Z] Plastic If"Yes" No. per If"Yes" No. per DGlaSS 'Certification **must** Unit Packaging wgt. Container Package wgt. Container DPaper **be submitted**  0.023 11 oz (0.67 ml) 0.045 f1 oz (1.34 ml)1 3 vials 

## I DOther(Specify) Plastic Bag 0.091 11 oz (2.68 ml) 0.136 f1 oz (4.02 ml) 3. Location of Net Contents Information 4. Size(s) Relail Conlainer 5. Location of Label Directions k8JLabel 

# o Container 0.67 ml, 1.34 ml, 2.68 ml, 4.02 ml Don Can [ZlOn Labeling accompanying product 6. Manner in Which Label is Affixed to Product DLithograph [Z]Other DPaperglued DStenCiJed 

# -'- Section IV 1. Contact Point (Complete items direcVybe/owfor identificatfon oftndfvidua/to be contacted, ifnecessary, to orocessJhis aonlicati':>r) , Name Title 

# 11 elephone No. (Inc!ude Area Code) Kelly R. Hoskins Manager ofTechnical Affairs

. '

# 4(1;':~8J8-7079 Certification 6. Date Application I certify that the statements I have made on this form and all attachments thereto are true, accurate and complete. I Re<;eived acknowledge that any knowingly false or misleading statement may be punishable by fine or imprisonment or both (Stamped) under applicable law. 2. Signature 

# \{o

# sG.H

# I:C/tJ 3. Title BY: 

# ILJ!\j- 12 Manager ofTechnical Affairs
4. Typed Name: 5. Oate: 08/11/2010 Kellv R. Hoskins Form Approve JMB No 20700060 Approval expires 05-31 98 Please rerrdInstructfons on reverse before \. Ip/etfng fonn -, 

### - - United States 1l;1Registration OPP Identifier Number 

# EPA Environmental Protection Agency D_Amendment Washington, DC 20460 

# o Other Application for Pesticide - Section I 1. Company/Product NumbeR 2. EPA Product Manager 3. Proposed Classification 2517-NEW 

### R U Richard Gebken 4. Company/Product (Name) 5.PM# 10 L8JNone DRestricted Sergeant's Pet Care Products, Inc. / Sergeants Fipronil + NylarSqueezeOn For DOQS 5. Name and Address ofApplicant (/nclude ZIP Code) 6. Expedited Review. In accordance with AFRA Section 3(c)(3)(b)(I), my Sergeant's Pet Care Products, Inc. product is similar or identical in composition and labeling to: 2625 South 158\11 Plaza Omaha, NE 68130-1770 EPA Reg. No. Product Name 

# o Check ifthis is a new address Section II 

# o Amendment

- Explain below. 

# D Final printed labels in response to Agency letter dated XX-XX-XX 

# o Resubmission in response to Agency letter dated XX-XX-XX 

# o "Me Too" Application 

# o Notification

- Explain below. other

- Explain below. Explanation: Use additional page(s) if necessary. (For section I and Section 11.) Submissior. of a new end-use registration application.
Section III 1. Material This Product Will Be Packaqed In: Child-Resistant Packaging Unit Packaging WaterSoluble Packaging 2 Type of Container 

# o Yes'**~Yes** DYes D Metal DNo D No 

## l:8J No [Z] Plastic If"Yes" No. per If"Yes" No. per DGlaSS 'Certification **must** Unit Packaging wgt. Container Package wgt. Container DPaper **be submitted**  0.023 11 oz (0.67 ml) 0.045 f1 oz (1.34 ml)1 3 vials 

## I DOther(Specify) Plastic Bag 0.091 11 oz (2.68 ml) 0.136 f1 oz (4.02 ml) 3. Location of Net Contents Information 4. Size(s) Relail Conlainer 5. Location of Label Directions k8JLabel 

# o Container 0.67 ml, 1.34 ml, 2.68 ml, 4.02 ml Don Can [Zlon Labeling accompanying product 6. Manner in Which Label is Affixed to Product DLithograph [Z]Other DPaperglued DStenCiJed 

# -'- Section IV 1. Contact Point (Complete items direcVybe/owfor identificatfon oftndfvidua/to be contacted, ifnecessary, to orocessJhis aonlicati':>r) , Name Title 

# 11 elephone No. (Inc!ude Area Code) Kelly R. Hoskins Manager ofTechnical Affairs . '

# 4(1;':~8J8-7079 Certification 6. Date Application I certify that the statements I have made on this form and all attachments thereto are true, accurate and complete. I Re<;eived acknowledge that any knowingly false or misleading statement may be punishable by fine or imprisonment or both (Stamped) under applicable law. 2. Signature 

# \{o

# sG.H

# I:C/tJ 3. Title BY: 

# ILJ!\j- 12 Manager ofTechnical Affairs
4. Typed Name: 5. Oate: 08/11/2010 Kellv R. Hoskins481894.00 Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com 

### August 11,2010 Richard Gebken, PMI0 Office ofPesticidePrograms (7504P) (REGFEE) 

### U.S. Environmental ProtectionAgency DocumentProcessingDesk Room 8-4900, One PotomacYard 

### 2777 South Crystal Drive Arlington, VA 22202 Subject: 

### Sergeant's Fipronil + Nylar Squeeze-On for Dogs EPA File Symbol 25I7-NEW Dear

### Mr. Gebken: Sergeant's Pet CareProducts, Inc. (Sergeant's, 2625 South 158'" Plaza, 

### Omaha, NE 68130-1770, 

### EPA CompanyNumber2517) is submitting an EPAregistration application forthe new end-use product Sergeant's Fipronil 

### +Nylar Squeeze-On for Dogs 

### [containingthe EPAregistered active ingredients Fipronil (9.8%) andPyriproxyfen (Nylar) (2.0%)]. Please find enclosed the following documentation in support 

### ofthis registration: 

### (I) Transmittal Document; (2) Application for Registration (EPAFonn 8570-1); (3) Confidential Statement ofFonnula (EPAFonn 8570-4) (Two Copies); (4) Fonnulator's Exemption Statement(EPAFonn 8570-27); (5) CertificationWith Respectto Citation ofData (EPA Fonn 8570-34); (6) DataMatrix (EPAFonn 8570-35)

- EPA and Public Versions; (7) Product Label (Five Copies); (8) Letter ofAuthorization; 

### (9) ChildResistantPackaging (CRP) Certification Statement; (10) Bridging Argumentto Cite CRP Data; (II) Submission ofEPAPesticideRegistration ImprovementAct Infonnation; (12) Voluntary Small Business Certification Fonn; (13) PRIA Fee Waiver Certification Statement; (14) PRIAFee Waiver Snpport Letter; (15) RecentEPA Approval of50% Small Business WaiverRequest (D-425455); (16) PRIA Category R310, Payment ConfinnationReceipt; and (17) Three Copies ofSupporting Studies. The registration ofSergeant's Fipronil 

### + Nylar Squeeze-On for Dogs is aselective citation registration for anew end-use product. Sergeant's is submitting newproduct chemistry studies in support 

### ofthis end-useproduct registration. Additionally, Sergeant's is citing acute toxicity 

### studies and companion animal safety data submitted to EPA onJune 18, 2010 withthe registration application for Sergeant's Fipronil 

### + Cyphenothrin Squeeze-On for Dogs. The acute 481894..00 Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com 

### August 11,2010 Richard Gebken, PMlO Office ofPesticide Programs (7504P) (REGFEE) U.S. Environmental Protection Agency DocumentProcessing Desk Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202 Subject: Sergeant's Fipronil 

### + Nylar Squeeze-Onfor Dogs EPA File Symbol 2517-NEW Dear

### Mr. Gebken: Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 158th 

### Plaza, 

### Omaha, NE 68130-1770, EPA Company Number 2517) is submitting an EPAregistration application forthe new end-use product Sergeant's 

### Pipronil 

### +Nylar Squeeze-On for Dogs [containing the EPA registered active ingredients Fipronil (9.8%) and Pyriproxyfen (Nylar) (2.0%)]. Please find enclosed the following documentation in support ofthis registration: (1) Transmittal Document; (2) Application for Registration (EPA Form 8570-1); (3) Confidential Statement ofFormula (EPA Form 8570-4) (Two Copies); (4) Formulator's Exemption Statement (EPA Form 8570-27); (5) CertificationWith Respectto Citation ofData (EPA Form 8570-34); (6) DataMatrix (EPA Form 8570-35)

- EPA and Public Versions; (7) Product Label (Five Copies); (8) LetterofAuthorization; (9) ChildResistantPackaging (CRP) Certification Statement; (10) Bridging Argumentto Cite CRP Data;

. (11) Submission ofEPA Pesticide Registration ImprovementAct Information; (12) Voluntary Small Business Certification Form; (13) PRIA Fee Waiver Certification Statement; (14) PRIAFee Waiver Support Letter; (15) RecentEPA Approval of50% Small Business WaiverRequest (0-425455); (16) PRIA Category R31 0, Payment ConfirmationReceipt; and (17) Three Copies ofSupporting Studies. The registration ofSergeant's Fipronil 

### + Nylar Squeeze-Onfor Dogs is a selective citation registration for a new end-use product. Sergeant's is submitting new productchemistry studies in support ofthis end-useproductregistration. Additionally, Sergeant's is citing acute toxicity studies and companion animal safety data submitted to EPA onJune 18,2010 with the registration application for Sergeant's Fipronil 

### + Cyphenothrin Squeeze-On for Dogs. The acutesargeant's Pet Care ProdUcts, Inc. 2625 South 1581t1 Plaza • Omaha, NE 68130·1nO • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com 

### toxicity studies were conducted on a '<soup" that contains multiple active ingredients that canbe bridged across multiple fonnulated end-use products. This registration application is considered aPRIA CategoryR310 (new end-use product) with a PRIAreviewtime of6 months. Sergeant's submitted aPRIA Small Business WaiverRequest under separate cover on April 14, 2010, and it was approved by EPA on May 4, 2010. A copy of 

### this approval letter

### is enclosed. We look forward to workingwiththe Agencyto register Sergeant's Fipronil + 

### Nylar SqueezeOn for Dogs. 

### If

### you have anyquestions or need additional infonnation regardingthis registration application, please contactme at 402-938-7079. Sincerely, 

# 0**~suw** 

# I e-A-T Kelly R. Hoskins Manager ofTechnical Affairs 

### Enclosures sargeant's Pet Care ProdUcts, Inc.

2625 South 1581t1 Plaza • Omaha, NE 68130·1nO • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com 

### toxicity studies were conducted on a '<soup" thatcontains multiple active ingredients thatcanbe bridged across multiple fonnulated end-useproducts. This registration applicationis considered aPRIA Category R310 (new end-useproduct) with a PRIAreview time of6 months. Sergeant's submitted a PRIA Small Business WaiverRequest under separate cover on April 14, 2010, anditwas approvedby EPA onMay 4,2010. A copy of this approval letteris enclosed. We look forward to working withthe Agency to register Sergeant's Fipronil 

### +Nylar SqueezeOnfor Dogs. 

### Ifyou have anyquestions orneed additional information regarding this registration application, please contactme at 402-938-7079. Sincerely, 

# 0**~suw** 

# I e-A-T Kelly R. Hoskins ManagerofTechnical Affairs Enclosures

### TRANSMITTAL DOCUMENT NAME AND ADDRESS OF SUBMITTER: 

### Sergeant's Pet CareProducts, Inc. 2625 South 158'" Plaza Omaha, NE 68130-1770 CONTACT PERSON (Return

### to) Kelly R. Hoskins 

### Sergeant's Pet CareProducts, Inc. 2625 South 158'" Plaza Omaha, NE 68130-1770 REGULATORY ACTION SUPPORTED BY THIS PACKAGE: 

### This submission is preparedto support an EPAregistration application for the new end-use product Sergeant's Fipronil 

### + Nylar Squeez(}-Qn forDogs. SUBMITTAL DATE: August 11, 2010

Volwne StudyTitle MRIDNo. 1 

### Administrative Materials 2 Group A Product Chemistry For Sergeant's Fipronil 

### + Nylar 48189401 Squeez(}-Qn For Dogs 

### 3 

### Group B 

### Product ChemistryFor Sergeant's Fipronil 

### +Nylar 49189402 Saueeze-On For Dogs 

### TRANSMITTAL DOCUMENT NAME AND ADDRESS OF SUBMITTER: 

### Sergeant's Pet CareProducts, Inc. 2625 South 158'" Plaza Omaha, NE 68130-1770 CONTACT PERSON (Return

### to) Kelly R. Hoskins 

### Sergeant's Pet CareProducts, Inc. 2625 South 158'" Plaza Omaha, NE 68130-1770 REGULATORY ACTION SUPPORTED BY THIS PACKAGE: 

### This submission is preparedto support an EPAregistration application for the new end-use product Sergeant's Fipronil 

### + Nylar Squeez(}-Qn forDogs. SUBMITTAL DATE: August 11, 2010

Volwne StudyTitle MRIDNo. 1 

### Administrative Materials 2 Group A Product Chemistry For Sergeant's Fipronil 

### + Nylar 48189401 Squeez(}-Qn For Dogs 

### 3 

### Group B 

### Product ChemistryFor Sergeant's Fipronil 

### +Nylar 49189402 Saueeze-On For Dogs

### Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza • Omaha, NE 68130·1770 • Telephone 402,938.7000 • Fax 402,938.7091 • www.sergeants,com



### August 11, 20I0 Richard Gebken, PMIO Office ofPesticide Programs (7504P) 

### U.S. Environmental ProtectionAgency Document Processing Desk Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202 

### Subject: Child Resistant Packaging Certification Sergeant's Fipronil 

### +Nylar §.gl1eeze-On for Dogs EPA File Symbol 25I7-j)IEW 

### (<\.til.
Dear Mr. Gebken: I certify that the packaging used for the following productmeets the standards of40 CFR 157.32, 

### including the revised standards in 16 CFR 1700.15(b), when tested bythe revised testing procedures in 16 CFR 1700.20, as published in 60 FR 37710 (July 21, 1995):

• Sergeant's Fipronil 

### +Nylar Squeeze-On for Dogs (EPA File Symbol 2517-NEW) Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 158'hPlaza, Omaha, NE 68130-1770, 

### EPA CompanyNumber 2517) is submittingthis child resistant packaging certification to support for the new end-use product Sergeant's Fipronil 

### + Nylar Squeeze-On for Dogs (EPA File Symbol 2517-NEW). All product labels have language specifying the use ofscissors to open the 

### product container and label language 

### stating the product is not to be applied bychildren. Ifyou have any questions, please contact me at402-938-7079. Sincerely,

Kelly R. Hoskins 

### Manager ofTechnical 

### Affairs

cc: LarryNouvel Sergeant's Pet Care Products, Inc.

2625 South 158th Plaza • Omaha, NE 68130·1770 • Telephone 402,938.7000 • Fax 402,938.7091 • www.sergeants,com



### August 11,2010 Richard Gebken, PMIO Office ofPesticide Programs (7504P) U.S. Environmental ProtectionAgency Document Processing Desk Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202 Subject: Child Resistant Packaging Certification Sergeant's Fipronil 

### +Nylar §.gl1eeze-On for Dogs EPA File Symbol 2517-pIEW 

## V<\J.RDear Mr. Gebken: I certify that the packaging used for the following productmeets the standards of40 CFR 157.32, including the revised standards in 16 CFR 1700.15(b), when tested by the revised testing procedures in 16 CFR 1700.20, as published in 60 FR 37710 (July 21, 1995):

• Sergeant's Fipronil 

### +Nylar Squeeze-On for Dogs (EPAFile Symbol 2517-NEW) Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 1581h

### Plaza, Omaha, NE 68130-1770, EPA CompanyNumber2517) is submitting this child resistant packaging certification to support for the new end-useproduct Sergeant's Fipronil 

### + Nylar Squeeze-On for Dogs (EPA File Symbol 25l7-NEW). All product labels have language specifying the use ofscissors to open the product container and label language stating the product is not to be appliedby children. Ifyou have any questions, please contactme at402-938-7079. Sincerely,

Kelly R. Hoskins Manager ofTechnical Affairs

cc: Larry NouvelForm Al'I'ro,<" O,\IU No. 10711-<1060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY III 

### 401 M Street, S.W. WASHINGTON, D.C. 20460 Plillernork Redlletion Act NOliee; TIle public rcporting burdcn for thi:; colleclion of**~llormalion** is c:;tinwlcd 10 avcrage 0.25 homs per response lor registrali0n**a~:il'i(jes** anJ::J-25 :H'Urs pcr rc,pon'c l:u reregislr;rtion and special rcview aClivilies, including timc for rcading lhe**inslru~tion** and completing lhe necessary forms Selld COllllllents regarding the burde:1**est:~lla:e** or anrotller;lSpect oft:lis**c,:llc~tion** or illfommlion, including suggestions for rcdllcing the hurdeu to Director: OI'PE lnfonnation Management Division (2137) U.S. Environmcnlal Pmtcetion Agency, 401 .'VI Slrce', ':;-W 'V1shillg·C1.;- OC :;0460. Do nOl send lhe form 10 this address. 

### DATA MATRIX -av.-I'Z. Date: Au ust II. 2010 EPA Rcg No./File S mbol**2:::~l?~NE;~(-~** Page I of4 Applicant's/Registnlnl'S Namc & Address Product: Scrgeant's Fipronil .;:**Nylar3~IJeez\:-** Sergcallt's Pet Care products, Inc. 2625 Soutll 158th Plaza, Olnaha, NE 68130-1770 On for Dogs In rcdicnts: Fi ronil and Nylar Guidelinc Rcfcrencc Number Guideline Stud Name MRIDNumber Submitter Status Note 830.1550, 830.1600, 830.1620, GrOllp A Product Chemistry For Sergeant's Flpronil + Nylar New submission Scrgeant's Pet Care Products, Inc. OWN 830.1650,830.1670,830.1750 Squeeze-On for Do,gs 830.1800 Enforeentent Analytical Method 48122601 Sergeant's Pet Care Products, Inc. OWN 830.6302,830.6303,830.6304, Group B Product Chcmistry For Sergeant's Fipronil + Nylar New submission Sergeant's Pct Carc Products, Inc. OWN 830.6313, 830.6314, 830.6315, Squccze-On for Dogs 830.6316, 830.6317, 830.6319, 830.6320, 830.6321, 830.7000, 830.7100,830.7300,830.7520 830.6317.830.6320 Storage stability and corrosion characteristics To Bc Submitted Sergeant's Pet Care Prodllcts, Inc. OWN Unon Comnletion 870.1100 Acute Oral Toxicity Up and Down Proccdurc with Dog Products 48129603 Sergcant's Pct Care Prodllcts, Inc. OWN
870.1200 Acute Dcrmltl Toxicity (Limit Test) with Dog Products 48129604 Scrgcant's Pct Care Products, Inc. OWN
870.1300 Waivcr Requesl ofRequirement for Further Tesling for Acute 48129605 Scrgeant's Pet Care Products, Inc. OWN Inhalalion Toxicitv 870.2400 Acutc Eyc Irritation/Corrosion with Dog Prodllcts 48129606 Scrgeant's Pet Care Products, Inc. OWN
870.2500 Acutc Dermal Irritation/Corrosion with Dog Produets 48129607 Sergcant's Pet Care Products, Inc. OWN
870.2600 Tcst for Sensitization (Guinea Pig Maxilllisation Test) with Dog 48t29608 Sergeant's Pct Carc Products, Inc. OWN Producls 870.7200 Companion Animal Safety for Scrgcant's Fipronil + Cyphenothrin 48129614 Sergeant's Pet Care Products, Inc. OWN SQueeze-On for Dogs 870.7200 Companion Animal Safety Evaluation on Dogs ofSpot-On 47849609 Scrgeant's Pet Care Products, Inc. OWN Prodllcts Containing Multiple Toxicants and Insect Growth Rc,gulators 870.7200 Companion Animal Safety Study ill Dogs: Cyphenothrin-IGR Spot- 46166108 Sergeant's Pct Carc Products, Inc. OWN on for Dogs 870.7200 Assessment ofTolcrance ofaO.25% RM 1601 Spray Formulation 43121110 Merial Limited OLD in Dogs at3, 9, and 15 Inl/kg When Applicd 6timcs to the 1·laircoat at 28 Dav Intervals Signature:

# ~'1- 

# t-**\:\-Dblu~** 

# j-t;i\T Name and Title Date Kclly R. f-Ioskills, Manager ofTedlllical Affairs 08/11/2010**""~ .~,o,**  «"

.." fo.q

.... "**"~o'r** """ ",n_ Vm;o",o ",,,,",',1.**<,"h~:' ~"'",** **P.~.",_"<,~"** A.,n,,·lnl.,n.' 11,. ('Onv 

### £- 

## 517- KLV\, Fo,mAI'I"O'c" O,\IU No. 10711-<1060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY III 

### 401 M Street, S.W. WASHINGTON, D.C. 20460 Plillernork Redlletion Act NOliee; TIle public rcporting burdcn for thi:; colleclion of**~llormalion** is c:;tinwlcd 10 avcrage 0.25 homs per response lor registrali0n**a~:il'i(jes** anJ::J-25 :H'Urs pcr rc,pon'c l:u reregislr;rtion and special rcview aClivilies, including timc for rcading lhe**inslru~tion** and completing lhe necessary forms Selld COllllllents regarding the burde:1**est:~lla:e** or anrotller;lSpect oft:lis**c,:llc~tion** or illfommlion, including suggestions for rcdllcing the hurdeu to Director: OI'PE lnfonnation Management Division (2137) U.S. Environmcnlal Pmtcetion Agency, 401 .'VI Slrce', ':;-W 'V1shillg·C1.;- OC :;0460. Do nOl send lhe form 10 this address. 

### DATA MATRIX -av.-I'Z. Date: Au ust II. 2010 EPA Rcg No./File S mbol**2:::~l?~NE;~(-~** Page I of4 Applicant's/Registnlnl'S Namc & Address Product: Scrgeant's Fipronil .;:**Nylar3~IJeez\:-** Sergcallt's Pet Care products, Inc. 2625 Soutll 158th Plaza, Olnaha, NE 68130-1770 On for Dogs In rcdicnts: Fi ronil and Nylar Guidelinc Rcfcrencc Number Guideline Stud Name MRIDNumber Submitter Status Note 830.1550, 830.1600, 830.1620, GrOllp A Product Chemistry For Sergeant's Flpronil + Nylar New submission Scrgeant's Pet Care Products, Inc. OWN 830.1650,830.1670,830.1750 Squeeze-On for Do,gs 830.1800 Enforeentent Analytical Method 48122601 Sergeant's Pet Care Products, Inc. OWN 830.6302,830.6303,830.6304, Group B Product Chcmistry For Sergeant's Fipronil + Nylar New submission Sergeant's Pct Carc Products, Inc. OWN 830.6313, 830.6314, 830.6315, Squccze-On for Dogs 830.6316, 830.6317, 830.6319, 830.6320, 830.6321, 830.7000, 830.7100,830.7300,830.7520 830.6317.830.6320 Storage stability and corrosion characteristics To Bc Submitted Sergeant's Pet Care Prodllcts, Inc. OWN Unon Comnletion 870.1100 Acute Oral Toxicity Up and Down Proccdurc with Dog Products 48129603 Sergcant's Pct Care Prodllcts, Inc. OWN
870.1200 Acute Dcrmltl Toxicity (Limit Test) with Dog Products 48129604 Scrgcant's Pct Care Products, Inc. OWN
870.1300 Waivcr Requesl ofRequirement for Further Tesling for Acute 48129605 Scrgeant's Pet Care Products, Inc. OWN Inhalalion Toxicitv 870.2400 Acutc Eyc Irritation/Corrosion with Dog Prodllcts 48129606 Scrgeant's Pet Care Products, Inc. OWN
870.2500 Acutc Dermal Irritation/Corrosion with Dog Produets 48129607 Sergcant's Pet Care Products, Inc. OWN
870.2600 Tcst for Sensitization (Guinea Pig Maxilllisation Test) with Dog 48t29608 Sergeant's Pct Carc Products, Inc. OWN Producls 870.7200 Companion Animal Safety for Scrgcant's Fipronil + Cyphenothrin 48129614 Sergeant's Pet Care Products, Inc. OWN SQueeze-On for Dogs 870.7200 Companion Animal Safety Evaluation on Dogs ofSpot-On 47849609 Scrgeant's Pet Care Products, Inc. OWN Prodllcts Containing Multiple Toxicants and Insect Growth Rc,gulators 870.7200 Companion Animal Safety Study ill Dogs: Cyphenothrin-IGR Spot- 46166108 Sergeant's Pct Carc Products, Inc. OWN on for Dogs 870.7200 Assessment ofTolcrance ofaO.25% RM 1601 Spray Formulation 43121110 Merial Limited OLD in Dogs at3, 9, and 15 Inl/kg When Applicd 6timcs to the 1·laircoat at 28 Dav Intervals Signature:

# ~'1- 

# t-**\:\-Dblu~** 

# j-t;i\T Name and Title Date Kclly R. f-Ioskills, Manager ofTedlllical Affairs 08/11/2010

EP", Fo:m S,7(1.15 (9.91) [I[«ro":oandP'p<r V",io", """'bbl, S"bmilc"ly P.pe' "<:>:0" Agcn,]"lnlr<n.1 11" Copy'Pl'**~<"<)'** 11'P,J"'; rO'm "pp'ond**O~lll** No, 20711-0%0 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 Papcnvork Rcduclinn Acl Nolicc: The public reporting bllrdCIi for lhis collcclion of**~lfQ(malion** is cSlimaled 10 averagc 0,25 hours Ilcr response for rL'gislralion aclivilies**aI1'1025~"I'rs** per**·('~rons71or** (ercgislmliOIl and special (eview aClivilies, incklding lime for (eadillg lhe illSlruelion and complelillglhc neccssary forms. SClid conllllClts (cga/ding lhe bmdcn cslimale 01 any olheraspeel oflhis collecrioll ofillfomlalion, inclu(ling suggeslions for red...,;:ing thc burden 10 Oircclm: 01'1'1, Infomlalion Managcnlenl**Divisil~l** (2137) U.S. Ellviwnmenlal I'rolcclioo Agency, 401 MSlreel, S.W" Washinglon, DC 20460. Do nnl send Ihc fonn 10lhis add(ess.



### --- 

### DATA MATRIX Dale: AUj!usl II. 20I0 EPA Rcg NoJFilc Symbol 7517-NEW

### ~"**~Pal!.c** 2 of4 Applicanl's1Rcgislrant's Name & Addrcss Producl: Sergeant's Fipronil + Nylar Squcezc-On Sergeant's Pel Care Products, Inc. 2625 S01llh 1581h Plaza, Omaha, NE 68130-1770 lor D02:S ?,1ti\1'" '{-2.W1t IngredienlS: Fipronil and Nvlar Guideline Reference Nnmber Guidclinc Siudy Namc MRID Number Snbmiltcr Status NOle 870.7200 Domeslic Animal SafclY: Assessmcnt oflhe Tolerancc ofa 0.25% RM 43121111 Medal Lilllited OLD 1601 Spray in Nursing Puppies Administcrcd Twicc al a 28 Day Interval al a Dosc Ratc 01'6 ml/kg 870.7200 Domcslic Animal Safcly Siudy ofRM 160le Topical Spray (Fronllinc 43444905 Melial Limiled OLD Spray Trcalment) in Juvcnile Dous 870.7200 Discussion in Support ofBridging Domeslic Animal Safcly Dala on 43577711 Melial Limiled OLD Pronl\ine Sora' Trealmcnllo Frontline Spot Trealment Dala Paekaue 870.7200 Domeslic Animal SafelY Siudy by '[opical Adminislralion 10 Dogs: 43863802 Merial Limitcd OLD Pioronil Soot Trealmeni (RM 1601£)' 810.3300 Overview and Summary ofPipronillCyphcnolhrin Dog Efficacy for 48129609 Sergeant's Pct Carc Products, Inc. OWN Sergeant's Fipronil + Cyphenothrin Soueeze-On for OMS 810.3300 Immediate Efficacy ofa Combined Applicalion ofPronilinc Plus 48129610 Sergeant's Pel Carc Producls, Inc. OWN wilh Cyphenothrin as a Squeeze-on againsl Fleas (Ctenocephalides felis) and Ticks (Rhivicevhallls sanfmineus) 011 Dogs 8\1l.3300 Immcdialc Efficacy FollowingApplicalion ofFronlline Plus wilh 48129611 Sergeanl's Pct Carc Producls, Inc. OWN Cyphcnolhrin Squeczl:-on againsl Fleas**(Ctenoceplwlides/efi~)** and Ticks (RhiJice ,hahlS san.c:uhle);;i on Oops 810.3300 Immediale Efficacy Following Applicalion ofFronlline wilh 48129612 Scrgcanl's Pcl Care ProduclS, Inc. OWN Cyphenothrin Squeezc-on againsl Fleas (Ctenocephalides/elis) and Ticks (RhinicelJlwl/(s sanPldnells! on DOl!s 810.3300 Comparalive efficacy evalualion ofSergeani's Squeeze-on and Fronlline 48129613 Scrgcanl's Pct Carc Producls, Inc. OWN Plus for Ihc Irealment ofaduli cat flea (Ctenocephalidesfelis) and tick (Haemaphysalis efliptica, RMpicephalus sallgJ/ineli/>' and Dermacentor variabifis) infeslalions on dops 8)0,3300 A Dose Tilration Study 10 Determine lhe Oplimal Spray Concenlralion 43121114 Medal Limiled OLD ofRM IUGI for Long Tcrm Conlrol oflhc Cal Fica Ctcnocephalides felis and lhe Brown Dog Tick Rhipicephalus sanguineus in Ihe Dog 810.3300 Produci Perforlllance: A Dose Confinnalion Siudy 10 Verify Ihc 431211 15 Menal Limiled OLD Oplimal Spray Concenlralion <IfRM 1601 for Long Rcsidual Conlrol of thc Cal Pica (Ctcnoccphalides lelis) and Ihc Brown Dog Tick (Rhipicephalus sanguineus) in Ihc Dol" Signalure: 

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# !''tAI Name and Tille Dale Kl:l1y R. Hoskins, Mamlgl:r orTt:chnical AlTairs 08/1lf2010

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### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 Papcnvork Rcduclinn Acl Nolicc: The public reporting bllrdCIi for lhis collcclion of**~lfQ(malion** is cSlimaled 10 averagc 0,25 hours Ilcr response for rL'gislralion aclivilies**aI1'1025~"I'rs** per**·('~rons71or** (ercgislmliOIl and special (eview aClivilies, incklding lime for (eadillg lhe illSlruelion and complelillglhc neccssary forms. SClid conllllClts (cga/ding lhe bmdcn cslimale 01 any olheraspeel oflhis collecrioll ofillfomlalion, inclu(ling suggeslions for red...,;:ing!hc burden 10 Oircclm: 01'1'1, Infomlalion Managcnlenl**Divisil~l** (2137) U.S. Ellviwnmenlal I'rolcclioo Agency, 401 M Slreel, S.W" Washinglon, DC 20460. Do nnl send Ihc fonn 10lhis add(ess.



### --- 

### DATA MATRIX Dale: AUj!usl II. 20I0 EPA Rcg NoJFilc Symbol 7517-NEW

### ~"**~Pal!.c** 2 of4 Applicanl's1Rcgislrant's Name & Addrcss Producl: Sergeant's Fipronil + Nylar Squcezc-On Sergeant's Pel Care Products, Inc. 2625 S01llh 1581h Plaza, Omaha, NE 68130-1770 lor D02:S ?,1ti\1'" '{-2.W1t IngredienlS: Fipronil and Nvlar Guideline Reference Nnmber Guidclinc Siudy Namc MRID Number Snbmiltcr Status NOle 870.7200 Domeslic Animal SafclY: Assessmcnt oflhe Tolerancc ofa 0.25% RM 43121111 Medal Lilllited OLD 1601 Spray in Nursing Puppies Administcrcd Twicc al a 28 Day Interval al a Dosc Ratc 01'6 ml/kg 870.7200 Domcslic Animal Safcly Siudy ofRM 160le Topical Spray (Fronllinc 43444905 Melial Limiled OLD Spray Trcalment) in Juvcnile Dous 870.7200 Discussion in Support ofBridging Domeslic Animal Safcly Dala on 43577711 Melial Limiled OLD Pronl\ine Sora' Trealmcnllo Frontline Spot Trealment Dala Paekaue 870.7200 Domeslic Animal SafelY Siudy by '[opical Adminislralion 10 Dogs: 43863802 Merial Limitcd OLD Pioronil Soot Trealmeni (RM 1601£)' 810.3300 Overview and Summary ofPipronillCyphcnolhrin Dog Efficacy for 48129609 Sergeant's Pct Carc Products, Inc. OWN Sergeant's Fipronil + Cyphenothrin Soueeze-On for OMS 810.3300 Immediate Efficacy ofa Combined Applicalion ofPronilinc Plus 48129610 Sergeant's Pel Carc Producls, Inc. OWN wilh Cyphenothrin as a Squeeze-on againsl Fleas (Ctenocephalides felis) and Ticks (Rhivicevhallls sanfmineus) 011 Dogs 8\1l.3300 Immcdialc Efficacy FollowingApplicalion ofFronlline Plus wilh 48129611 Sergeanl's Pct Carc Producls, Inc. OWN Cyphcnolhrin Squeczl:-on againsl Fleas**(Ctenoceplwlides/efi~)** and Ticks (RhiJice ,hahlS san.c:uhlel;;i on Oops 810.3300 Immediale Efficacy Following Applicalion ofFronlline wilh 48129612 Scrgcanl's Pcl Care ProduclS, Inc. OWN Cyphenothrin Squeezc-on againsl Fleas (Ctenocephalides/elis) and Ticks (RhinicelJlwl/(s sanPldnells! on DOl!s 810.3300 Comparalive efficacy evalualion ofSergeani's Squeeze-on and Fronlline 48129613 Scrgcanl's Pct Carc Producls, Inc. OWN Plus for Ihc Irealment ofaduli cat flea (Ctenocephalidesfelis) and tick (Haemaphysalis efliptica, RMpicephalus sallgJ/ineli/>' and Dermacentor variabifis) infeslalions on dops 8)0,3300 A Dose Tilration Study 10 Determine lhe Oplimal Spray Concenlralion 43121114 Medal Limiled OLD ofRM IUGI for Long Tcrm Conlrol oflhc Cal Fica Ctcnocephalides felis and lhe Brown Dog Tick Rhipicephalus sanguineus in Ihe Dog 810.3300 Produci Perforlllance: A Dose Confinnalion Siudy 10 Verify Ihc 431211 15 Menal Limiled OLD Oplimal Spray Concenlralion <IfRM 1601 for Long Rcsidual Conlrol of thc Cal Pica (Ctcnoccphalides lelis) and Ihc Brown Dog Tick (Rhipicephalus sanguineus) in Ihc Dol" Signalure: 

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# !''tAI Name and Tille Dale Kl:l1y R. Hoskins, Mamlgl:r orTt:chnical AlTairs 08/llf2010 El'AForm**~57C>-lS** 9_97 EI«"oni<aod P, <I VmiOMA",lil,hl< SUO,,,;) 0,,1' p, Iv

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.. CoFo"" "1'I"Oq'<I**o~lO** 1'0. 2010·0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

### ,..- 401 M Street, S.W. WASHINGTON, D.C. 20460**!'~pen\'ork** Rcduction Act Noticc: Tile public rcportillgburden for t1lis collection of**iufonn~liou** is eSlilll<lled 10avcragc 0.25 hours per rcspollSC for rcgistra:k;;:acliiilies <Ind·O.25 l;Gms !-'cr**r~,pon,;C7"r** rcrcgi:;lfalion and spccial review aelivilies, including Iilllc forreadillg Ille instfllction and conlplclillgIhc ncccssary lorlnS, Scud commentsregarding Ihc burdcn**esti~na~~** Dr any-Dtller**:~,pcet** oft::is celle;lion of illlbrmalion, includiug sllggcslions for reducing thc burdcn 10 Dircclor: OPPE InfDrlnalion Munugcllleni Divi,ioll (2 137) U.S. Environlnenlal Prolcctioll Agcncy, 40t M Strect, $, W" Wasllingtoll, OC L0460. Do nOI send Ihe fonn to Ihis address. 

### DATA MATRIX Date: AligUSt I I, 20I0 

# --""- EPA Re No.lFile S mbol**2~17"01E',~gL\\":~.** __ Pa 'e 3 of4 Applieant's/Registrant's Name & Address Product: Sergennt's FiproniI**~-:Nylar ~queezc-**  

## :i Seweant's Pet Care Products, Inc. 2625 South 158tll Plaza, Omaha, NE 68130-1770 On for Dogs 

### ,'0 Ingrediellts: Fipronil alld Nylnr Guidelillc Referenec Number Guidelille Studv Name MRID Number Submitter Statlls Note 810.3300 A Comparalive Evaluation ofTwo Trentment Regimes Usillg RM 43121116 Medal Limited OLD 160I Spray for COll\rol ofthe Cat Flea Ctenoeephalides felis 1lI1 the Doe 810.3300 Laboratory E"aluation ofRM 1601 Spray for Control Dermncenlor 43121117 Medal Linlited OLD variabilis alld RhiDeceDlmlus sanguineus 011 tile Dol!. 810.3300 An Ilivestigatioll Stlldy to Evaluate the Effect ofBatllillg of 43121118 Merial Limited OLD Laboratorv Oops on tile Effieoc 'ofRM1601 Snra 810.3300 Efficacy ofRM 160lC at 3 ml/kg and 6 ml/kg Against Ixodes 43121122 Merial Limited OLD scapularis/dammilli Nymphs, Dermacentor variabilis N)'lllplls, Amblyomilia ailierieanum Nymphs, Rhipicephalus sanguineus Nymphs, and Ctenocephalides felides Adults UsingTreated Dog Hair as the Testiol!: Subslrate 810.3300 Positive Referelleed and Untreated Conlrolied, ConfirmatOIY 43577712 Medal Limited OLD Laborntory Trial ofRM 160IE SPOT-ON Formulation Applied 10 Dogs as 3 Weigllt Class Defilled Volumes for tile Control oftile Cat Flea Ctelloeephalides felis, the Brown Dog Tick Rllipieephalus sanrruineus, and tile Alneriean Dol" Tick Dermacentor variabilis 810.3300 An Efficacy Study ofFrolllline Spray, Frontline Top Spot, a1td ML- 45620501 Merial Limited PAY 2,095,988 509T, for the Treatment and Control ofTricllodeetes canis in the DOl! 810.3300 Studv Summaries: Frontline Plus For Dogs 45612701 Medal Limited PAY 810.3300 PR & 0 002410 I: Frontline Spray/Frontline Spot-OIl/ML-2, 095, 988 45620504 Merial Limited PAY 509'1'/DOl!S ISolutionIToDieal 810.3300 PR & 0 005230 I: Frolltline Spray/Frontline SpOI-01I/ML-2, 095, 988 45620505 Medal Linlited PAY 509'1'/Dogs/Solution / Tonieal 810.3300 Study to Confirm the Efficacy ofFipronil Against Lice in Dogs Ullder 45628201 Merial Limited PAY rield Conditions 8103300 Frolltline Spray & Top Spot! Dogs/Solutioli/Topieal CIinial/Dose 45620506 Merial Limited PAY Confirmation/ EetoDarasites, Mites, Sa.rcoples Scabiei var canis 810.3300 A Study to Evaluate the Efficacy ofFrontline Plus for Control of 45866902 Medal Limited PAY Mosquitoes, Aedes aegypti, on Dogs 810.3300 Dose Titration ofa Pyriproxyfen Spot-On Formulatioll For Flea Ova 46346601 Sergeallt's Pet Care Prodllets, Ille. OWN Sterilization. Sigllature: 

# \:CeLL(\- 

# 11.-- t\osllivJ.l1 rr\-T Name and Title Date Kelly R. Hoskins, Manager ofTeclmieal AITairs 08/1112010 EI','r",n, S57(1.)5 (9·'" IEI'Cl""n,<**an~** 1"1'''" v",io", A"jIMI, S"om;' only Pap", """ion**"~,,,«y** h".rn.III«Cop.'

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# :1 517 

## .1<\.IviZ EI" 1oro, S57(1.)5 (9 IEI'Cl""m**an~** P'p,," V"'", 01 AlJI, S om only Pap", ",,,on Fo"" "1'I"Oq'<I**o~lO** 1'0. 2010·0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

### ,..- 401 M Street, S.W. WASHINGTON, D.C. 20460**!'~pen\'ork** Rcduction Act Noticc: Tile public rcportillgburden for t1lis collection of**iufonn~liou** is eSlilll<lled 10avcragc 0.25 hours per rcspollSC for rcgistra:k;;:acliiilies <Ind·O.25 l;Gms !-'cr**r~,pon,;C7"r** rcrcgi:;lfalion and spccial review aelivilies, including Iilllc forreadillg Ille instfllction and conlplclillgIhc ncccssary lorlnS, Scud commentsregarding Ihc burdcn**esti~na~~** Dr any-Dtller**:~,pcet** oft::is celle;lion of illlbrmalion, includiug sllggcslions for reducing thc burdcn 10 Dircclor: OPPE InfDrlnalion Munugcllleni Divi,ioll (2 137) U.S. Environlnenlal Prolcctioll Agcncy, 40t M Strect, $, W" Wasllingtoll, OC L0460. Do nOI send Ihe fonn to Ihis address. 

### DATA MATRIX Date: AligUSt I I, 20I0 

# --""- EPA Re No.lFile S mbol**2~17"01E',~gL\\":~.** __ Pa 'e 3 of4 Applieant's/Registrant's Name & Address Product: Sergennt's FiproniI**~-:Nylar ~queezc-**  

## :i Seweant's Pet Care Products, Inc. 2625 South 158tll Plaza, Omaha, NE 68130-1770 On for Dogs 

### ,'0 Ingrediellts: Fipronil alld Nylnr Guidelillc Referenec Number Guidelille Studv Name MRID Number Submitter Statlls Note 810.3300 A Comparalive Evaluation ofTwo Trentment Regimes Usillg RM 43121116 Medal Limited OLD 160I Spray for COll\rol ofthe Cat Flea Ctenoeephalides felis 1lI1 the Doe 810.3300 Laboratory E"aluation ofRM 1601 Spray for Control Dermncenlor 43121117 Medal Linlited OLD variabilis alld RhiDeceDlmlus sanguineus 011 tile Dol!. 810.3300 An Ilivestigatioll Stlldy to Evaluate the Effect ofBatllillg of 43121118 Merial Limited OLD Laboratorv Oops on tile Effieoc 'ofRM1601 Snra 810.3300 Efficacy ofRM 160lC at 3 ml/kg and 6 ml/kg Against Ixodes 43121122 Merial Limited OLD scapularis/dammilli Nymphs, Dermacentor variabilis N)'lllplls, Amblyomilia ailierieanum Nymphs, Rhipicephalus sanguineus Nymphs, and Ctenocephalides felides Adults UsingTreated Dog Hair as the Testiol!: Subslrate 810.3300 Positive Referelleed and Untreated Conlrolied, ConfirmatOIY 43577712 Medal Limited OLD Laborntory Trial ofRM 160IE SPOT-ON Formulation Applied 10 Dogs as 3 Weigllt Class Defilled Volumes for tile Control oftile Cat Flea Ctelloeephalides felis, the Brown Dog Tick Rllipieephalus sanrruineus, and tile Alneriean Dol" Tick Dermacentor variabilis 810.3300 An Efficacy Study ofFrolllline Spray, Frontline Top Spot, a1td ML- 45620501 Merial Limited PAY 2,095,988 509T, for the Treatment and Control ofTricllodeetes canis in the DOl! 810.3300 Studv Summaries: Frontline Plus For Dogs 45612701 Medal Limited PAY 810.3300 PR & 0 002410 I: Frontline Spray/Frontline Spot-OIl/ML-2, 095, 988 45620504 Merial Limited PAY 509'1'/DOl!S ISolutionIToDieal 810.3300 PR & 0 005230 I: Frolltline Spray/Frontline SpOI-01I/ML-2, 095, 988 45620505 Medal Linlited PAY 509'1'/Dogs/Solution / Tonieal 810.3300 Study to Confirm the Efficacy ofFipronil Against Lice in Dogs Ullder 45628201 Merial Limited PAY rield Conditions 8103300 Frolltline Spray & Top Spot! Dogs/Solutioli/Topieal CIinial/Dose 45620506 Merial Limited PAY Confirmation/ EetoDarasites, Mites, Sa.rcoples Scabiei var canis 810.3300 A Study to Evaluate the Efficacy ofFrontline Plus for Control of 45866902 Medal Limited PAY Mosquitoes, Aedes aegypti, on Dogs 810.3300 Dose Titration ofa Pyriproxyfen Spot-On Formulatioll For Flea Ova 46346601 Sergeallt's Pet Care Prodllets, Ille. OWN Sterilization. Sigllature: 

# \:CeLL(\- 

# 11.-- t\osllivJ.l1 rr\-T Name and Title Date Kelly R. Hoskins, Manager ofTeclmieal AITairs 08/1112010

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.. COI'Y EPA Form 8,7<J.)5 t9·91) Elcc>roc" acd Paper Versiocs A"ilabk Submi, cnly P'perY''''O" Form Approwd OMU No. 20JO·OO6U 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 Paperwork Itednetion Act Noliee: The public rqlOl1ing burden for tllis collection ofinfom1alion is estimaled 10 average 0.25 hours per response for regislraiilln aeoivides alld li,25 hr;urs per**re~pome** f<lr reregiSlrmion and special revict\' activities. including time for reading lhe instmetion and completing Ihe necessary forllls. Send eommenlS regarding tile burden eSlinDle or ar:y',:>Jle, :,sj)ect Ofli,L eoiketiull or infonJ1alion, inehlding suggestions for reducing lhe burden 10 Director: OPPE Inlormatioll MalJa,gcmclIl**Di~ision** (2137) U.S. Environmental ProtectionAgency, 401 M Street, S.W" Washington, OC 20460. Do nol send lhe form tuthis address. 

### DATA MATRIX 

# /tR Date: AUIJust II, 20I0 EPA Re No./File S mbol**25i7-.N£\~~** Pa e40f4 Applicanl's/Registmnt's Name & Address Product: Sergeant's Pipronil +l'-:)Idr SqueczeSergeant's Pet Care Producls, Inc, 2625 South 1581h Plaza, Omaha, NE 68130-1770 On for Dogs In;redients: Fi':'ronil and**N~;lar** Guideline Reference Number GuidelilJe Study Name MRIDNumber Sublnilter Status Note 810,3300 Analyses ofellielle)' and safety data to support label claims for 47849608 Sergeant's Pet Care Products, Inc. OWN Sergeant"s squeeze-on for small dogs containing etofenprox lind n\lrinroxyfen 40 CFR Part 157.32 Evalll!ltilln ofthe Dog Squeeze On 0.67 IJJI White Applicalnr with 48059803 Sergeant's Pet Care Products, Inc. OWN Orange Labelilidieator (3x), scissors to open - P=I as a Poison Prevention Paekaoe for Seraeant's Pet Care Products, Inc, 40 CPR Part 157.32 Evaillation orthe Dog Squeeze On 1,34 tnl While Applicator wilh 48059804 Sergeant's Pet Care Products, Inc. OWN Green Label Indicator (3x), scissors to open - P=-I as a Poison Prevention Packap-e for**S~;Qeanl'S** Pel Care Products, Inc. 40 CFR Pari 157.32 Evaluation ofthe Dog Squeeze On 2.68 ml White Applicator with 48059805 Sergeant's Pet Care Products, Inc. OWN Red Label Indicator (3x), scissors 10 npen - P= I as a Poison Prevention Paeka"e for SerIJeant's Pet Care Products, Inc. 40 CPR Part 157.32 Evaillation ofthe Dog Squeeze On 4.02 ml White Applicator with 48059806 Sergeltnl's Pet Care Products, Inc. OWN Blue Label Indicator (3x), scissors to open - P=I as a Poison Prevention**Pack-a~~** for**S~rp-eant's** Pet Care Products, Inc.

Signature:

# I?Ll~ 

# ci?-**\\o.\..~;**

# i~:fJ-'i Name a1Jd Title Date Kelly R. l-loskins, Manager ofTechnical Affairs 08/11/2010 '---,



## Il-RvQ. FormApprowd OMU No. 20JO·OO6U 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 Paperwork Itednetion Act Noliee: The public rqlOl1ing burden for tllis collection ofinfom1alion is estimaled 10 average 0.25 hours per response forregislraiilln aeoivides alld li,25 hr;urs per**re~pome** f<lr reregiSlrmion and special revict\' activities. including time for reading lhe instmetion and completing Ihe necessary forllls. Send eommenlS regarding tile burden eSlinDle or ar:y',:>Jle, :,sj)ect Ofli,L eoiketiull or infonJ1alion, inehlding suggestions for reducing lhe burden 10 Director: OPPE Inlormatioll MalJa,gcmclIl**Di~ision** (2137) U.S. Environmental ProtectionAgency, 401 MStreet, S.W" Washington, OC20460. Do nol send lhe form tuthis address. 

### DATA MATRIX 

# /tR Date: Au ustll,2010 EPA Re No./File S mbol

### 25i7-.w0.~~ Page 4 of4 Applicanl's/Registmnt's Name & Address Product: Sergeant's Pipronil +l'-:)Idr SqueczeSergeant's Pet Care Producls, Inc, 2625 South 1581h Plaza, Omaha, NE 68130-1770 On for Dogs In redients: Fi ronil and N ,Iar Guideline Reference Number GuidelilJe Study Name MRIDNumber Sublnilter Status Note 810,3300 Analyses ofellielle)' and safety data to support label claims for 47849608 Sergeant's Pet Care Products, Inc. OWN Sergeant"s squeeze-on for small dogs containing etofenprox lind pvrjproxyfen 40 CFR Part 157.32 Evalll!ltilln ofthe Dog Squeeze On 0.67 IJJI White Applicalnr with 48059803 Sergeant's Pet Care Products, Inc. OWN Orange Labelilidieator (3x), scissors to open - P=I as a Poison Prevention Paeka"e for Sen'-eant's Pet Care Products, Inc, 40 CPR Part 157.32 Evaillation ofthe Dog Squeeze On 1,34 tnl While Applicator wilh 48059804 Sergeant's Pet Care Products, Inc. OWN Green Label Indicator (3x), scissors to open - P=-I as a Poison Prevention Packa'e for Semeanl's Pel Care Products, Inc. 40 CFR Pari 157.32 Evaluation ofthe Dog Squeeze On 2.68 ml White Applicator with 48059805 Sergeant's Pet Care Products, Inc. OWN Red Label Indicator (3x), scissors 10 npen - P= Ias a Poison Prevention Package for Sergeant's Pet Care Products, Inc. 40 CPR Part 157.32 Evaillation ofthe Dog Squeeze On 4.02 ml White Applicator with 48059806 Sergeltnl's Pet Care Products, Inc. OWN Blue Label Indicator (3x), scissors to open - P=I as a Poison Prevention PackaQe for Semeant's Pet Care Products, Inc.

Signature: 

# \?Ll\\- 

# ci?-**\\o.\..~;** 

# i**~:fJ-'i** Name a1Jd Title Date Kelly R. l-loskins, Manager ofTechnical Affairs 08/11/2010 EPA Form 8,7!),)5 t9·91)Elcc>ron" llIldPo rVersion, A"ilobk Submi,nnlyP'pery,,,,o" Ag,o,)' 10"en.1 U

.. COI'YSergeant's Pet Care Products, Inc. 2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com


### August 11,2010 Rosalind Gross c/o Richard Gebken Registration Division Office ofPesticide Prograrus (7504P) U.S. Environmental Protection Agency Document Processing Desk Room 8-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202 Subject: Child ResistantPackaging Information**Ser~t's** 

### Fipronil 

### + Nylar Squeeze-On for Dogs (EPA File Symbol: 2517- 

### ,JlI-EW)

# rVAl

.. Dear Ms. Gross: Sergeant's Pet Care Products, Inc. (Sergeants, 2625 South 158'" Plaza, Omaha, NE 68130-1770, EPA CompanyNumber 2517) is submitting arequest to rely on previously submitted Child ResistantPackaging (CRP) studies to supportthis new registration. The CRP data were submitted to EPA on April 12, 2010 in support ofthe pending registration applications under EPA File Symbols: 2517-RGT, 2517-RGA, 251 7-RGL, and 2517-RGU (all ofwhich contain Fipronil at 9.7-9.8%). Sergeant's generated CRP data on a standard white applicator in sizes 0.67, 1.34,2.68, and 4.02 mL. The following is a summarytable ofthe applicators that were tested and submitted to EPA in the CRP data:
Use ApplicatorBase Color 

## mu Weight (mLl Color 

### Dog Uo to 22 lbs White 

### 0.67 OranQ:e 

### Doe 23-44 Ibs White 

### 1.34 

### Green Dog 45-881bs White 

### 2.68 Red Dog 89-132 Ibs White 

### 4.02 Blue 

### CRP datais required for this new productbecause ofthe inclusion ofthe active ,ingredieIit fipronil (9.8%) in the pet squeeze-onproduct. The CRP testing was conducte4 on a:standard package size and colorconfigurationthatis identical for this product. The**Serg~3.~!'s** 

### Fip;'oaU .:- Nylar Squeeze-On for Dogs productbeing submitted today also contains**fiproni~** 

### at'9.8%, Additionally, Sergeant's already has dog squeeze-onproducts approved by EPA ccntaining

## 2% Nylar (EPA Registration Numbers 2517-127 through 2517-129) that are not s"hjectto CRP. This new product contains 2% nylar.



### 1 Sergeant's PetCare Products, Inc. 2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com


### August 11,2010 Rosalind Gross c/o Richard Gebken Registration Division Office ofPesticide Programs (7504P) U.S. Environmental Protection Agency Document Processing Desk Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202 Subject: Child ResistantPackaging Information**~_~~t's** 

### Fipronil 

### + Nylar Squeeze-On for Dogs (EPA File Symbol: 2517-

### ~) rlJ..,(l.. 

### Dear Ms. Gross: Sergeant's Pet Care Products, Inc. (Sergeants, 2625 South 158th 

### Plaza, Omaha, NE 68130-1770, EPA Company Number 2517) is submitting arequest to rely onpreviously submitted Child ResistantPackaging (CRP) studies to supportthis new registration. The CRP data were submitted to EPA on April 12, 2010 in support ofthe pending registration applications under EPAFile Symbols: 25l7-RGT, 25l7-RGA, 2517-RGL, and 25l7-RGU (all ofwhich contain Fipronil at 9.7-9.8%). Sergeant's generated CRP data on a standard white applicator in sizes 0.67, 1.34,2.68, and 4.02 mL. The following is a summarytable ofthe applicators that were tested and submitted to EPA in the CRP data:
Use ApplicatorBase Color FiU Weight (roL) Color Dog Up to 22 lbs White 0.67 Orange Dog 23-44 lbs White 1.34 

### Green Dog 45-88lbs White 2.68 Red Dog 89-132 lbs White 4.02 Blue

- 

### CRP datais required for this new productbecause ofthe inclusion ofthe active ,ingredient fipronil (9.8%) in the pet squeeze-onproduct. The CRP testing was conducte4 on a:standard' package size and colorconfigurationthatis identical for this product. The**Serg~3.~!~s** 

### Fip;'oaU .:- Nylar Squeeze-On for Dogs productbeing submitted today also contains**fiproni~** 

### at:9.8%, Additionally, Sergeant's already has dog squeeze-onproducts approvedby EPA centailing'

## 2% Nylar (EPA Registration Numbers 2517-127 through 2517-129) that are not s11hjectto CRP. 'This new product contains 2% nylar.

1Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza • Omaha, NE 68130-1nO • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeams.com Furthennore, Sergeant's does not anticipate any additional toxicity through the combination of fipronil and nylar. When Sergeant's Fipronil 

### + Nylar Squeeze-On for Dogs is marketed, it will utilize the same applicator color (white) and fill weight colors permL fill weight as was used in the submitted and referenced CRP testing. Based on available infonnation, the density range of the pendingproducts on which the CRP data were generated is the same as the new product (1.0- 1.5 

### gr/cc). Therefore, Sergeant's is relying on MRlD's: 48059803, 48059804, 48059805, and 48059806 to fulfill the CRP data requirements for Sergeant's Fipronil 

### +Nylar Squeeze-On for Dogs. Ifyou have any questions, please contact me at402-938-7079. Sincerely,

Kelly R. Hoskins Manager ofTechnical Affairs

cc: LarryNouvel

2 Sergeant's 

### Pet Care Products, Inc. 2625 South 158th Plaza • Omaha, NE 68130-1nO • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeams.com 

### Furthennore, Sergeant's does not anticipate any additional toxicity through the combination of fipronil and nylar. When Sergeant's Fipronil 

### + Nylar Squeeze-On for Dogs is marketed, itwill utilize the same applicator color (white) and fill weight colors permL fill weight as was used in the submitted and referenced CRP testing. Based on available infonnation, the density range of the pendingproducts on which the CRP data were generated is the same as the new product (1.0- 1.5 gr/cc). 

### Therefore, Sergeant's is relying onMRlD's: 48059803, 48059804, 48059805, and 48059806 to fulfill the CRP data requirements for Sergeant's Fipronil 

### +Nylar Squeeze-On for Dogs. Ifyou have any questions, please contact me at402-938-7079. Sincerely,

Kelly R. Hoskins Manager ofTechnical Affairs

cc: LarryNouvel

2Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.93&7091 • www.sergeants.com 

### August II, 2010 Richard Gehken, PMIO Office ofPesticide Programs (7504P) (REGFEE) 

### U.S. Environmental Protection Agency Document ProcessingDesk Room S-4900, One PotomacYard 2777 South Crystal Drive Arlington, VA 22202 Suhject: 

### Sergeant's Fipronil +

### Nylar Squeeze--On for Dogs EPAFile Symho12517-NEW 

### DearMr. Gebken: Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 158ili 

### Plaza, Omaha, NE 68130-1770, 

### EPA CompanyNumber 2517) is submitting an EPAregistration application for the new end-use product Sergeant's Epronil 

### +Nylar Squeeze-On for Dogs [containingthe EPAregistered active ingredients Fipronil (9.8%) and Pyriproxyfen (Nylar) (2.0%)]. Please find enclosed the 

### following documentation in support ofthis 

### registration: (1) Transmittal Document; (2) Application for Registration (EPA Form 8570-1); (3) Confidential Statement ofFormula (EPAForm 8570-4) (Two Copies); (4) Formulator's Exemption Statement (EPAForm 8570-27); (5) Certification With Respect to Citation ofData (EPAForm 8570-34); (6) Data Matrix (EPAForm 8570-35)

- EPA and Public Versions; (7) Product Label (Five Copies); 

### (8) Letter ofAuthorization; (9) Child Resistant Packaging (CRP) Certification Statement; (10) Bridging Argumentto Cite CRP Data; 

### (11) Submission ofEPA 

### Pesticide Registration ImprovementAct Information; (12) Voluntary Small Business CertificationForm; (13) PRIAFee Waiver Certification Statement; (14) PRIA FeeWaiver Support Letter; (15) Recent EPA Approval of50% Small Business WaiverRequest (D-425455); (16) PRIA Category R31 0, Payment Confirmation Receipt; and (17) Three Copies ofSupporting Studies. 

### The registration ofSergeant's 

### Fipronil +Nylar Squeeze-On for Dogs is a selective citation registration for anew end-use product. Sergeant's is submitting newproduct chemistry studies in support ofthis end-use productregistration. Additionally, Sergeant's is citing acute toxicity studies and companion animal safety data submitted to EPAon June 18, 2010 with the registration application for Sergeant's Fipronil 

### + Cyphenothrin Squeeze-On for Dogs. The acute Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.93&7091 • www.sergeants.com 

### August 11, 2010 Richard Gebken, PMI0 Office ofPesticide Programs (7504P) (REGFEE) U.S. Environmental Protection Agency Document Processing Desk Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202 Subject: Sergeant's Fipronil 

### +Nylar Squeeze--On for Dogs EPAFile Symbol 2517-NEW DearMr. Gebken: Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 158th 

### Plaza, Omaha, NE 68130-1770, EPA CompanyNumber2517) is submitting an EPAregistration application for the new end-use product Sergeant's Fipronil 

### +Nylar Squeeze-On for Dogs [containing the EPAregistered active ingredients Fipronil (9.8%) and Pyriproxyfen (Nylar) (2.0%)]. Please find enclosed the following documentation in support ofthis registration: (1) Transmittal Document; (2) Application for Registration (EPA Form 8570-1); (3) Confidential Statement ofForrnula (EPAForm 8570A) 

### (Two Copies); (4) Formulator's Exemption Statement (EPAForm 8570-27); (5) Certification With Respect to Citation ofData (EPAForm 8570-34); (6) Data Matrix (EPAForm 8570-35) EPA and Public Versions; (7) Product Label (Five Copies); (8) LetterofAuthorization; (9) Child Resistant Packaging (CRP) Certification Statement; (10) Bridging Argumentto Cite CRP Data; (11) Submission ofEPA Pesticide Registration ImprovementAct Information; (12) Voluntary Small Business CertificationForm; (13) PRIAFee Waiver Certification Statement; (14) PRIA FeeWaiver Support Letter; (15) Recent EPA Approval of50% Small Business WaiverRequest (D-425455); (16) PRIA Category R31 0, Payment Confirmation Receipt; and (17) Three Copies ofSupporting Studies. The registration ofSergeant's Fipronil 

### +Nylar Squeeze-On for Dogs is a selective citation registration for a new end-useproduct. Sergeant's is submitting new product chemistry studies in support ofthis end-useproductregistration. Additionally, Sergeant's is citing acute toxicity studies and companion animal safety data submitted to EPA onJune 18, 2010 with the registration application for Sergeant's Fipronil 

### + Cyphenothrin Squeeze-On for Dogs. The acuteSergeant's Pet Care Products, Inc. 2625 South 158th Plaza • Omaha, NE 68130·1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com 

### toxicity studies were conducted on a "soup" that contains multiple active ingredients that canbe bridged across multiple formulated end-use products. This registration application is considered a PRIA Category R31 0 (new end-use product) with a PRIAreview time of6 months. Sergeant's submitted a PRlA Small Business WaiverRequest under separate cover on April 14,2010, and it was approvedby EPA onMay 4, 2010. A copy of this approval letteris enclosed. We look forward to working with the Agency to register Sergeant's Fipronil 

### +Nylar SqueezeOn for Dogs. Ifyou have any questions orneed additional informationregarding this registration application, please contactme at 402-938-7079. Sincerely, 

# t\cSu.H 

# I 'H\,T Kelly R. Hoskins Manager ofTechnical Affairs Enclosures Sergeant's Pet Care Products, Inc.

2625 South 158th Plaza • Omaha, NE 68130·1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com 

### toxicity studies were conducted on a "soup" that contains multiple active ingredients that canbe bridged across multiple formulated end-use products. This registration application is considered a PRIA Category R31 0 (new end-use product) with a PRIAreview time of6 months. Sergeant's submitted a PRlA Small Business WaiverRequest under separate cover on April 14, 2010, and it was approvedby EPA onMay 4, 2010. A copy of this approval letteris enclosed. We look forward to working with the Agency to register Sergeant's Fipronil 

### +Nylar SqueezeOn for Dogs. Ifyou have any questions orneed additional informationregarding this registration application, please contactme at 402-938-7079. Sincerely, 

# t\cSu.H 

# I 'HI, 

# T Kelly R. Hoskins Manager ofTechnical Affairs EnclosuresTRANSMITTAL DOCUMENT NAME AND ADDRESS OF SUBMITTER: Sergeant's Pet Care Products, Inc. 2625 South 158"' Plaza Omaha, NE 68130-1770 CONTACT PERSON (Return to) Kelly R. Hoskins 

### Sergeant's Pet Care Products, Inc. 2625 South I58'h Plaza Omaha, NE 68130-1770
REGULATORY ACTION SUPPORTED BY THIS PACKAGE: 

### This submissionis prepared to supportan EPAregistration application for the new end-use product Sergeant's Fipronil 

### + Nylar Squeeze-On for Dogs. SUBMITTAL DATE: August 11, 2010

Volume Study Title MRIDNo. 

### 1 Administrative Materials 2 Group A Product Chemistry For Sergeant's Fipronil 

### + Nylar Squeeze-On ForDogs 

### 3 Group B Product Chemistry For Sergeant's Fipronil 

### +Nylar Squeeze-On ForDogs TRANSMITTAL DOCUMENT NAME AND ADDRESS OF SUBMITTER: Sergeant's Pet Care Products, Inc. 2625 South 158"' Plaza Omaha, NE 68130-1770 CONTACT PERSON (Return to) Kelly R. Hoskins 

### Sergeant's Pet Care Products, Inc. 2625 South I58'h Plaza Omaha, NE 68130-1770
REGULATORY ACTION SUPPORTED BY THIS PACKAGE: 

### This submissionis prepared to supportan EPAregistration application for the new end-use product Sergeant's Fipronil 

### + Nylar Squeeze-On for Dogs. SUBMITTAL DATE: August 11, 2010

Volume Study Title MRIDNo. 

### 1 Administrative Materials 2 Group A Product Chemistry For Sergeant's Fipronil 

### + Nylar Squeeze-On ForDogs 

### 3 Group B Product Chemistry For Sergeant's Fipronil 

### +Nylar Squeeze-On ForDogsForm approved. OMS No. 2070-0060, 2070-0057,**~.,** 0-01 07, 2070·0122, 2070-0t64. 

# & EPA
United States Environmental Protection Agency Washington, OC 20460 Formulator's Exemption Statement (40 CFR 152.85)



# -- Applicant's Namealld ,ll,'1dress EPA File Symbol/Registration Number Ser£eaJl1's Pet

### (.ar:: Products, Inc. 2517-NEW**26~5** 5:c\.;th 15'3LIIFlaza Product Name Omaha, NE**6813~-j770** Sergeant's FiproniJ + Nylar Squeeze-On for Dogs
Date ofConfidential Statement of Formula (EPA Form 8570-4) 08/11/2010 As an authorized representative ofthe applicant for registration ofthe product identified above, I certify that: (1) This product contains the following active ingredient(s): Fipronil Pyriproxyfen

(2) Ofthese, each active ingredient listed in paragraph (4) is present solely as the result ofthe use ot that active ingredient in the manufacturing, formulation or repackaging another product which contains that active ingredient whiCh is registered under FIFRA Section 3, is purchased by us from another person and meets the requirements of40 CFR section 158.50(e)(2) or (3). (3) Indicate by checking (A) or (8) belowwhich paragraph applies:

II (A) An accurate Confidential Statement of Formula (EPA FORM 8570·4) for the above identified product is attached to this statement. That formula statement indicates, by company name. registration number, and product name, the source ofthe active ingredient(s) listed in paragraph (1). OR


## -, (8) The Confidential Statement of Formula (CSF)(EPA Form 8570-4) reterenced above and on file with the EPA is complete, current, an accurate and contains the information required on the current CSF. (4) The following active ingredients in this product qualifyfor the formUlator's exemption.

SourCe Active Ingredient Product Name Registration Number Fipronil Technical

Pyriproxyfen

Signature

# \-\o~l..H

# /7fiT Name and Title Date 

# V-tLLLt- f/--- • Kelly R. Hoskins, Manager ofTechnical AlTai'lJ 08111/2010 EPA Form 8'fi70-27 (Rev. 06-2004) Copy 1 EPA Copy 2

- Applicant copy Form approved. OMS No. 2070-0060, 2070-0057,**~.,** 0-01 07, 2070·0122, 2070-0t64. 

# & EPA
United States Environmental Protection Agency Washington, OC 20460 Formulator's Exemption Statement (40 CFR 152.85)



# -- Applicant's Namealld ,ll,'1dress EPA File Symbol/Registration Number Ser£eaJl1's Pet

### (.ar:: Products, Inc. 2517-NEW**26~5** 5:c\.;th 15'3LIIFlaza Product Name Omaha, NE**6813~-j770** Sergeant's FiproniJ + Nylar Squeeze-On for Dogs
Date ofConfidential Statement of Formula (EPA Form 8570-4) 08/11/2010 As an authorized representative ofthe applicant for registration ofthe product identified above, I certify that: (1) This product contains the following active ingredient(s): Fipronil Pyriproxyfen

(2) Ofthese, each active ingredient listed in paragraph (4) is present solely as the result ofthe use ot that active ingredient in the manufacturing, formulation or repackaging another product which contains that active ingredient which is registered under FIFRA Section 3, is purchased by us from another person and meets the requirements of40 CFR section 158.50(e)(2) or (3). (3) Indicate by checking (A) or (8) belowwhich paragraph applies:

II (A) An accurate Confidential Statement of Formula (EPA FORM 8570·4) for the above identified product is attached to this statement. That formula statement indicates, by company name. registration number, and product name, the source ofthe active ingredient(s) listed in paragraph (1). OR


## -, (8) The Confidential Statement of Formula (CSF)(EPA Form 8570-4) reterenced above and on file with the EPA is complete, current, an accurate and contains the information required on the current CSF. (4) The following active ingredients in this product qualifyfor the formUlator's exemption.

SourCe Active Ingredient Product Name Registration Number Fipronil Technical

Pyriproxyfen

Signature

# \-\o~l..H

# /7fiT Name and Title Date 

# V-tLLLt- f/--- • Kelly R. Hoskins, Manager ofTechnical AlTai'lJ 08111/2010 EPA Form 8'fi70-27 (Rev. 06-2004) Copy 1 EPA Copy 2 - Applicant copyFonn Ar roved OM3 Nos. 2070-0060; 2070-{}057; 2070-{}107; 2070-{}122; 2070-0164

............. UNITED STATES ENVIRONMENTAL PROTECTION AGENCY**~~** 

# ,**~/** 1200 Pennsylvania Avenue, N.W. WASHINGTON, D.C. 20460 Paperwork ReductionAet Notiee: The publie reporting burden forthis eolketion ofinformation is estimated to average 1.25 hours per response for registration and 0.25 IIc'J"S ;n;c,ponse for reregistration and special rev;ewactivities, including timeforreadingthe instructions and complcting thc necessary rorms Send commcnts reil3Ttlingburden**Cstj.I\~(J"i** any othcraspectofthis collection ofinformation, inclilding suggcstiolls for reducing thc burden to: Director, Collection S(rntegies Divi"ion (2822n, ('.S. E1vironmenta! Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, DC 20460. Do not send the cOlnpktcd ronn to dlis address,**-'~-''''** 

## ---" Certification with Respect to Citation ofData Applicanfs/Rellistranfs Nan-.e, AddrvSs, and Telephone Number EPA Rellislration Number/File Symbol Sergeant's Pei Care Produrts, Inc.,'2625 South 1581h Plaza, Omaha, NE 68130·1770 2517·NEW



# ----- Adive InqreJie,rtlslandlorrepresentative lest compoundts) Date Fipmnil and Pyripmxyfen 08ltt/20tO General Use**P(.t~m(s}** (list al those claimed forthis product usin!! 40 CFR Part 158} Product Name Domestic indoor non-food Sergeant's Fipronil + Nylar Squeeze·On for Dogs NOTE: Ifyour product is a 100% repackaging of another purchased EPA-registered product labeled for**a~** the same uses on your label, you do not need to**subm~** this fonn. You mustsubmit the Fonnulato(s Exelllltion Statement (EPA Fonn 8570-27). 

# D I am responding to a Data-GalHn Notice, and have included with this fonn a**~st** of companies Sellt olfers ofcompensation (the Data Matrixform shoul;l be used for this purpose).

SECTION I: METHOD OF DATA SUPPORT (Check one method only) 

# D I am using the cite-all method ofsupport, and have included with this fonn 

## [2] I am using the selective method ofsupport (orcile-all option a list of companies Selltoffers ofcompensation (the Data Matrix form underthe selective method), and have included with this fonn a should be used forthis purpose}. completed list ofdata requirements (the Data Mabix fonn musl be used). SECTION tt: GEt£RAL OFFERlO PAY IRequired it using the**c~e-all** method orwhen using the dte-all option under the selective method 10 satisfy one or more dala requirements} 

# D I hereby offer and agree to pay compensation, to other persons, with regard to the approval ofthis application, to the extent required by FIFRA.

SECTION tit: CERTIFtCATION I certify that this application for registration, this form for reregistration, orthis Data-Call-In response is supported by all data submitted ordted in the application for registration, the fOrm for reregistration, orthe Data-Call·ln response. In addition, rfthe**c~e-all** oplion or cite-all option underthe selectrve method is indicated in Sedion t. this application is supported by all data in the Agency's files that (1) concem the properties oreffects ofthis product oran identical or substantially similar product, orone or more ofthe ingredients. in this product; and (2) is atype of data thatwoul;l be required to be submitted Ulderthe data requirements in effed on the dale ofapproval ofthls application if the application soughtthe initiat registration ofa product of identical or similar**compos~ion** and uses I certify that for each exclusive use study ciled n support ofthis registration or reregistration, that I am the originat data submillerorthat I have obtained the wrillen permission ofthe original data subffiitterto**c~e** that study, tcertify thatfor each study**c~ed** in support ofthis registration or reregistration that is notan eXclusive use study,**e~her;** (a) I am the original data submitter; (b) I have obtained the permission ofthe OIiginal data**subm~ter** to use the study in support ofthis application; (c) all periods ofeligibility for compensation have expired for the study; (d) the study is in the public literature; or (e) t have notified in**wr~ing** the company thai submitted the study and have offered (I) to pay compensation 10the extent required by sedions 3(c)(1)(F} andlor3(c)(2)(B} ofFIFRA; and (Ii) to commence negotiations to determine the amount and lerms ot compensation, rfany, to be paj:;! forthe use ofthe study, I certify that in all instances where an offer of compensation is required, copies of**a~** offers to pay compensation and evidence oftheirdetivery in accordance with sections 3(c}(1 }(F) and/or 3(cX2}(B} of FIFRA are available and will be submitted to the A{lenc.y upon request. ShotJd I fail to produce such evidence to the Agency upon request, I understand that the Agency may initiate action to deny, cancel or suspend the registration ofmy product in conformity**w~h** FIFRA. I certify that the statements t have mado on this form and all attachments to itarc true, accurae, and complete. I ackno

.....edge that any knowingty mise or mlsleadlrg statement may be puntshabte bj fine or imprisonment or both Under applicablo law. Signature

## fi<,,,Lu~ 

# !-:prT "", Typed or Printed Name and lille 

# 12

,..'- 08/11/2010 Kelly R. Hoskins, Manager ot Technical Affairs

. EPA Fonn 8570-34 (12 2003) Electrontc and Paper versions available. Submt only Paperversion

. Fonn Ar roved OM3 Nos. 2070-0060; 2070-{}057; 2070-{}107; 2070-{}122; 2070-0164

............. UNITED STATES ENVIRONMENTAL PROTECTION AGENCY**~~** 

# ,**~/** 1200 Pennsylvania Avenue, N.W. WASHINGTON, D.C. 20460 Paperwork ReductionAet Notiee: The publie reporting burden forthis eolketion ofinformation is estimated to average 1.25 hours per response for registration and 0.25 IIc'J"S ;n;c,ponse for reregistration and special rev;ewactivities, including timeforreadingthe instructions and complcting thc necessary rorms Send commcnts reil3Ttlingburden**Cstj.I\~(J"i** any othcraspectofthis collection ofinformation, inclilding suggcstiolls for reducing thc burden to: Director, Collection S(rntegies Divi"ion (2822n, ('.S. E1vironmenta! Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, DC 20460. Do not send the cOlnpktcd ronn to dlis address,**-'~-''''** 

## ---" Certification with Respect to Citation ofData Applicanfs/Rellistranfs Nan-.e, AddrvSs, and Telephone Number EPA Rellislration Number/File Symbol Sergeant's Pei Care Produrts, Inc.,'2625 South 1581h Plaza, Omaha, NE 68130·1770 2517·NEW



# ----- Adive InqreJie,rtlslandlorrepresentative lest compoundts) Date Fipmnil and Pyripmxyfen 08ltt/20tO General Use**P(.t~m(s}** (list al those claimed forthis product usin!! 40 CFR Part 158} Product Name Domestic indoor non-food Sergeant's Fipronil + Nylar Squeeze·On for Dogs NOTE: Ifyour product is a 100% repackaging of another purchased EPA-registered product labeled for**a~** the same uses on your label, you do not need to**subm~** this fonn. You mustsubmit the Fonnulato(s Exelllltion Statement (EPA Fonn 8570-27). 

# D I am responding to a Data-GalHn Notice, and have included with this fonn a**~st** of companies Sellt olfers ofcompensation (the Data Matrixform shoul;l be used for this purpose).

SECTION I: METHOD OF DATA SUPPORT (Check one method only) 

# D I am using the cite-all method ofsupport, and have included with this fonn 

## [2] I am using the selective method ofsupport (orcile-all option a list of companies Selltoffers ofcompensation (the Data Matrix form underthe selective method), and have included with this fonn a should be used forthis purpose}. completed list ofdata requirements (the Data Mabix fonn musl be used). SECTION tt: GEt£RAL OFFERlO PAY IRequired it using the**c~e-all** method orwhen using the dte-all option under the selective method 10 satisfy one or more dala requirements} 

# D I hereby offer and agree to pay compensation, to other persons, with regard to the approval ofthis application, to the extent required by FIFRA.

SECTION tit: CERTIFtCATION I certify that this application for registration, this form for reregistration, orthis Data-Call-In response is supported by all data submitted ordted in the application for registration, the fOrm for reregistration, orthe Data-Call·ln response. In addition, rfthe**c~e-all** oplion or cite-all option underthe selectrve method is indicated in Sedion t. this application is supported by all data in the Agency's files that (1) concem the properties oreffects ofthis product oran identical or substantially similar product, orone or more ofthe ingredients. in this product; and (2) is atype of data thatwoul;l be required to be submitted Ulderthe data requirements in effed on the dale ofapproval ofthls application if the application soughtthe initiat registration ofa product of identical or similar**compos~ion** and uses I certify that for each exclusive use study ciled n support ofthis registration or reregistration, that I am the originat data submillerorthat I have obtained the wrillen permission ofthe original data subffiitterto**c~e** that study, tcertify thatfor each study**c~ed** in support ofthis registration or reregistration that is notan eXclusive use study,**e~her;** (a) I am the original data submitter; (b) I have obtained the permission ofthe OIiginal data**subm~ter** to use the study in support ofthis application; (c) all periods ofeligibility for compensation have expired for the study; (d) the study is in the public literature; or (e) t have notified in**wr~ing** the company thai submitted the study and have offered (I) to pay compensation 10the extent required by sedions 3(c)(1)(F} andlor3(c)(2)(B} ofFIFRA; and (Ii) to commence negotiations to determine the amount and lerms ot compensation, rfany, to be paj:;! forthe use ofthe study, I certify that in all instances where an offer of compensation is required, copies of**a~** offers to pay compensation and evidence oftheirdetivery in accordance with sections 3(c}(1 }(F) and/or 3(cX2}(B} of FIFRA are available and will be submitted to the A{lenc.y upon request. ShotJd I fail to produce such evidence to the Agency upon request, I understand that the Agency may initiate action to deny, cancel or suspend the registration ofmy product in conformity**w~h** FIFRA. I certify that the statements t have mado on this form and all attachments to itarc true, accurae, and complete. I ackno

.....edge that any knowingty mise or mlsleadlrg statement may be puntshabte bj fine or imprisonment or both under applicablo law. Signature

## fi<,,,Lu~ 

# !-:prT "'" Typed or Printed Name and lille 

# 12

,..'- 08/11/2010 Kelly R. Hoskins, Manager ot Technical Affairs

. EPA Fonn 8570-34 (12 2003) Electrontc and Paper versions available. Submt only Paperversion

.

### R310
Must submit Group A and Bproduct chemistry data for each proposed product. End Use (EP) or Manufacturing Use (MP) product orTechnical Grade of the Active Ingredient (TGAI) / EP Data MP Data Guideline Group A: Product Chemistry Data Submitted Submitted TGAI No. Study Title Yes No Yes No Yes No 830.1550 Product Identitv & Composition ,/ Description of materials used to ,/ 830.1600 oroducetheoroduct 830.1650 Description of formulation process ,/ 830.1670 Discussion on the formation of impurities ,/ 830.1700 Preliminary analvsis ,/ 830.1750 Certified limits 1158.3451 ,/ 830.1800 Enforcement analvtical method (:'--j5 letT
. ,!rd' 

### ,/ -:l l( )

EP Data MP Data Guideline Group B: Product Chemistry Data Study Submitted Submitted TGAI No. Title Yes No Yes No Yes No 830.6302 Color 

## v 830.6303 Phvsical State ,/ 830.6304 Odor 

### ./ Stability to normal and elevated 830.6313 temperatures metal and metal ions Oxidation/Reduction ,/ 830.6314 (Chemical incomoatibilitvl 830.6315 Flammabilitv 

### ./ 830.6316 Exolodability 

# v 830.6317 Storaae stabilitv 

# v 830.6319 Miscibilitv 

# v 830.6320 Corrosion Characteristics v" 830.6321 Dielectric Breakdown Volto!=w v" 830.7000 oH 

### / 830.7050 UV/ Visible Absorotion 830.7100 Viscosity ,/ 830.7200 Meltino Point 830.7220 Boilina Point 830.7300 Densitv 

### / 830.7370 Dissociation Constant 830.7550 Partition Coefficient 830.7840 Water Solubilitv 830.7950 Vaoor Pressure Grayed out
- data not reqUired

] 

### R310
Must submit Group A and Bproduct chemistry data for each proposed product. End Use (EP) or Manufacturing Use (MP) product orTechnical Grade of the Active Ingredient (TGAI) 

### / EP Data MP Data Guideline Group A: Product Chemistry Data Submitted Submitted TGAI No. Study Title Yes No Yes No Yes No 

### 830.1550 Product Identity 

### & Composition 

### -/ Description of materials used to 

### ./ 830.1600 produce the product 

### 830.1650 Description of formulation process -/ 

### 830.1670 Discussion on the formation of impurities 

### / 830.1700 Preliminary analysis ,/ 

### 830.1750 Certified limits 

### (158.3451 

## / 830.1800 Enforcement analytical method 

### (:'is letT**~l('(:(d)** 

### -/ U
Guideline No. Group B: Title EP Data MP Data Product Chemistry Data Study f-S"-u....:;b:..;.m.:..:r-itt;..:::e;..:::d:......-r-S::...;u:...:;b::.:.m.:..:r-itt:....:::e:....:::d'------r-T_G_A_I-.-_---4 Yes No Yes No Yes No 

### 830.6302 Color Ph sical State Odor 

### 830.6304

830.6319 Miscibilit 

### 830.6303

Grayed out = data not required 

### 830.7220 Boilin Point 

### 830.7300 Densit 

### 830.7100 Viscosit 

### 830.6321 Dielectric Breakdown Volta e



### 830.7200 Meltin Point 

### 830.6317 Store e stabilit 

### 830.6316 Ex lodabilit 

### 830.6315 Flammabilit



### 830.7000 H 830.7050 UV/ Visible Absor tion Oxidation/Reduction 

### 830.6314 Chemical incom atibilit



### 830.6320 Corrasion Characteristics Stability to normal and elevated 

### 830.6313 tem eratures metal and metal ions



### 830.7950 Va or Pressure 

### 830.7370 Dissociation Constant 

### 830.7550 Partition Coefficient 

### 830.7840 Water Solubilit

1

## R310

New products must either: I) suppy the product specific acute toxicITy 6 pack data (nsted below), or 

### 2) provide a bridging rationale document. The bridging document directs opp to use a currently registered set of 6 acute toxicity data and label: instead of submitting product specific data.

Data Guideline Acute toxicity (6 pack) submitted Cited No. Study Title Yes No Yes No 

### 870.1100 Acute Oral 

### IL0501 

### ,/
870.1200 Acute Dermal 

### IL0501 

### 0/
870.1300 Acute Inhalation I

### Le50) 

### ,/
870.2400 Acute Eve Irritation 0/ 

### 870.2500 Acute Dermal Irritation 

### 0/ 870.2600 Dermal Sensitization 

### ,/

Efficacy

- which guideline is used depends on the proposed label use Data Guideline submitted Cited No. Study Title Yes No Yes No Comments 

### 810.3100 Soil Treatments for Imoorted Fire Ants Livestock, Poultry, Fur and Wool-Bearing 

### 810.3200 Animal Treatments Treatments to Contrd Pests of Humans and 

## ,/ 810.3300 Pets Mosquito. Black Fly. and Biting Midge 

### 810.3400 [Sand Ry) Treatments 

### 810.3500 Premises Treatments I 

### 810.3600 structural Treatments Methods for Efficacy Testing ofTermite 

### 810.3800 Baits



### 2 

## R310

New products must either: I) suppy the product specific acute toxicITy 6 pack data (nsted below), or 

### 2) provide a bridging rationale document. The bridging document directs opp to use a currently registered set of 6 acute toxicity data and label: instead of submitting product specific data.

Data Guideline Acute toxicity (6 pack) submitted Cited No. Study Title Yes No Yes No 

### 870.1100 Acute Oral 

### IL0501 

### ,/
870.1200 Acute Dermal 

### IL0501 

### 0/
870.1300 Acute Inhalation I

### Le50) 

### ,/
870.2400 Acute Eve Irritation 0/ 

### 870.2500 Acute Dermal Irritation 

### 0/ 870.2600 Dermal Sensitization 

### ,/

Efficacy

- which guideline is used depends on the proposed label use Data Guideline submitted Cited No. Study Title Yes No Yes No Comments 

### 810.3100 Soil Treatments for Imoorted Fire Ants Livestock, Poultry, Fur and Wool-Bearing 

### 810.3200 Animal Treatments Treatments to Contrd Pests of Humans and 

## ,/ 810.3300 Pets Mosquito. Black Fly. and Biting Midge 

### 810.3400 [Sand Ry) Treatments 

### 810.3500 Premises Treatments I 

### 810.3600 structural Treatments Methods for Efficacy Testing ofTermite 

### 810.3800 Baits



### 2

# Sergeant's® MasterLabel g,,/l.. II August 2010 Version 10.1 EPA Reg. No. 2517-)8( Infonnation in ( ] is optional. Page 1 of8 [CARTON LABEL

- DRAFT MASTER LABEL COPY] 

## Sergeant's Fipronil 

# + Nylar Squeeze-On for Dogs [ABNs) ®

...

# ~'pMrfj.J)- 

# r(} [(Sergeant's) (Sentry) VetSpotTM (Spot On) for dogs] 

### '-"...()UL LV [(Sergeant's®) (Sentry") VetSpotTM (Spot On) for dogs] [(Sergeant's®) (Sentry®) FRONTIER GOLD (Spot On) for dogs] [(Sergeant's®) (Sentry®) EctoadvanceTM (Spot On) for dogs]

[Apply to puppies over 12 weeks old] [Apply to puppies 12 weeks or older] 

### [. Flea & 

### Tick Control for Dogs & 

### Puppies 12 weeks old and older] [-For Dogs and Puppies 12 weeks ofage or older] [·For Dogs [up to 22Ibs], [23-44Ibs], [45-88Ibs], [89-132Ibs] [-Kills fleas, flea eggs, ticks, chewing lice & 

### mosquitoes] 

### [-Controls flea reinfestation for up to [12 weeks]] [·Fast Acting] 

### [-Kills ticks including those that may transmit Lyme disease] [-Dogs can be bathed 24 hours after treatment] ", ['Waterproof] [·Long Lasting] [-Research demonstrates that [brand name] kills adult fleas, flea eggs, flea larvae<L'l:! 

### pupae for up to three months.] [-[brand name] prevents development ofall flea stages for up to three months.] [-Kills fleas, ticks, mosquitoes, (chewing) lice, flea eggs, larvae and pupae] [-Prevents all flea stages (adult fleas, flea eggs, flea pupae and flea larvae)] [- Ifdog is a high risk for flea reinfestation a once a month application may be needed] [-Once a month treatment recommended] [-A once monthly application is recommended for chewing lice.] [-Rapidly eliminates infestations with chewing lice] [-Monthly flea, tick, mosquito, lice, and flea egg protection] [-Monthly flea, tick, mosquito and lice protection] [-Kills flea eggs [larvae] [pupae] for more than [63 days] [9 weeks]] [-Aids in Control ofSarcoptic Mange] [-Kills fleas, ticks, mosquitoes, flea eggs, and lice] [-[Seven] [7] Way Protection [Kills fleas, ticks, mosquitoes, lice, flea eggs, flea larvae and flea pupae]] [-6 [Six] Way Protection! Kills fleas, ticks, mosquitoes, lice, flea eggs & 

### flea larvae] [-[4 Week] [Flea and Tick & 

### Treatment]] ['[Four (4) Week] [Flea Tick, Mosquito and Lice Control] [-With Nylar® Insect Growth Regulator which Breaks the Flea Life Cycle] [-With Nylar® to Break Flea Life Cycle]**r---------~..** 

### ... 

# Sergeant's® Master Label

# ~u.~ 11 August 2010 Version 10.1 EPA Reg. No. 2517-XK Information in ( ] is optional. Page 1 of8 [CARTON LABEL

- DRAFT MASTER LABEL COPY] 

## Sergeant's Fipronil 

# + Nylar Squeeze-On for Dogs [ABNs] [(Sergeant's®)**(Sentry~** 

### VetSpotTM (Spot On) for dogs]**[(Sergeant's~!)** 

### (Sentry®) VetSpotTM (Spot On) for dogs] [(Sergeant's®) (Sentry®) FRONTIER GOLD (Spot On) for dogs] [(Sergeant's®) (Sentry®) EctoadvanceTM (Spot On) for dogs] 

# <:ct t • 

# _f)

-

# r{J**~pMUCX.fLV**

:. ,. <.**~ ~.** F ···.·.R·

.. ·O·

···.··N···T:.:· .•·p····

.•·•A:· N·.·.··.······E

.. ·t·············•.•·•.•·.·•••••• .•. :.:.•..•..••.•.••..•..•.••...•..•....•...•.....•.....••.....•.•.•.•..•.......•...•. -: •• ;;;............:.:·'r{:··.·.··.·.··.·

... .•...•......•.•..•.••.•..•..: ...••.....•.....:

.•....•..:

..•.•..•...•.......•....•.....•...•...•...••..•.•...•.•.•...•.....•.•.•.••......•.. : .•....: :.: ...........•.•.•..... :.: .••.•.•...•......•..•

_ ....••.....•.:.'

....•: .•....•.•...•.•....: : : : •.•.•. ······:·D· "'0"

···G······:.-SiiU·E

.. ·:E

..···Z·:E·· - O

..······N··



### .. ..<:·

......::...
...:.::i:···... . - ... .··(:

..**:;.EIeR~Ni~~N¥~~R** 

### [Apply to puppies over 12 

### weeks old] [Apply to puppies 12 

### weeks orolder] [- Flea & Tick Control for Dogs & Puppies 12 weeks old and older] [-For Dogs and Puppies 12 weeks ofage or older] [-For Dogs [up to 221bs], [23-441bs], [45-88 Ibs], [89-1321bs] [-Kills fleas, flea eggs, ticks, chewing lice & 

### mosquitoes] [-Controls flea reinfestation for up to [12 weeks]] [-Fast Acting] [-Kills ticks including those that may transmit Lyme disease] [-Dogs can be bathed 24 hours after treatment] [-Waterproof] [-Long Lasting] [-Research demonstrates that [brand name] kiUs adult fleas, flea eggs, flea larvae<L'l:! 

### pupae for up to three months.]

. . [-[brand name] prevents development ofall flea stages for up to three months.] [-Kills fleas, ticks, mosquitoes, (chewing) lice, flea eggs, larvae and pupae] [-Prevents all flea stages (adult fleas, flea eggs, flea pupae and flea larvae)] [- Ifdog is a high risk for flea reinfestation a once a month application may be needed] [-Once a month treatment recommended] [-A once monthly application is recommended for chewing lice.] [-Rapidly eliminates infestations with chewing lice] [-Monthly flea, tick, mosquito, lice, and flea egg protection] [-Monthly flea, tick, mosquito and lice protection] [-Kills flea eggs [larvae] [pupae] for more than [63 days] [9 weeks]] [-Aids in Control ofSarcoptic Mange] [-Kills fleas, ticks, mosquitoes, flea eggs, and lice] [-[Seven] [7] Way Protection [Kills fleas, ticks, mosquitoes, lice, flea eggs, flea larvae and flea pupae]] [-6 [Six] Way Protection! Kills fleas, ticks, mosquitoes, lice, flea eggs & 

### flea larvae] [-[4 Week] [Flea and Tick & 

### Treatment]] [-[Four (4) Week] [Flea Tick, Mosquito and Lice Control] [-With Nylar® Insect Growth Regulator which Breaks the Flea Life Cycle] [-With Nylar® to Break Flea Life Cycle]

# Sergeant's@ Master Label II August 2010 Version 10.1 EPA Reg. No. 2517-XX Information in 

## I ] is optional. Page 2 of8 

### [.With Insect Growth Regulator to Break Flea Life Cycle] [·Dual Action [I]: Fipronil with Nylar® lOREffectively Breaks the Flea Life Cycle] ['Dual Action [I]: Effectively Breaks the Flea Life Cycler!]] [·Three Applications {for cartons with 3 applicators}] and/or [3 Month Supply] or [12 Week Supply]] 

### [-Best ifused 

### year round!] [·Kills Fleas Up to [4 weeks!] [2 months] [3 months]] ['(ICON Showing 4 Week Protection)] [.4 Week Dose!] [,1 Month Dose!] ['Easy to Use Application] [-Specially Formulated for Dogs and Puppies] ['[Free] Calendar Stickers Inside!] 

### [-[Free] Brochure Inside!] [-[Free] Brochure and Calendar Stickers Inside] [·Patented Technology] [·Kills Flea Eggs & Flea Larvae for more than [63days], [9 weeks]!] 

### [-Prevents Flea Eggs From Developing Into Biting Adults] [·Kills Ticks for Up to [4 weeks]!] [-Kills [all stages of]Deer Ticks (vector ofLyme Disease) for up to 

### weeks] [-Kills Ticks (Including Deer Ticks) for up to 4 weeks] [·Kills [Brown], [American,] [and Lone Star ]Dog Ticks for up to 4 weeks; 

### [-Kills Rhipicephalus sanguineus 

### for up to 4 weeks] "

. 

### [-When used monthly [brand name] completely breaks the flea life cy<:,(e**~Jd** 

### controls tick and chewing lice infestations.] [-Kills American Dog Ticks [(Dermacentor variabilis)] 

### for up to 4 weeks!] ['Apply once every [4 weeks]!] 

### [-4 week Flea and Tick Treatment!] [Once A Month Flea and Tick Treatment] [-Kills Fleas and Ticks for up to 4 weeks!] ['Kills all stages ofthe fIea life cycle] 

### [-Kills Fleas, Ticks, Flea Eggs & 

### Flea Larvae for up to 4 Weeks] ['[Kills mosquitoes]] 

### [-Dogs can be bathed 24 hours after**squeeze~on** 

### is applied] [-Prevents and controls reinfestations] [-[Free with purchase] [Free inside] Monthly Application Reminder [Magnet] [clip] [card]] 

# Sergeant's® Master Label II August 2010 Version 10.1 EPA Reg. No. 2517-XX Information in 

## I ] is optional. Page 2 of8 

### [.With Insect Growth Regulator to Break Flea Life Cycle] [·Dual Action [I]: Fipronil with Nylar® lOREffectively Breaks the Flea Life Cycle] ['Dual Action [I]: Effectively Breaks the Flea Life Cycler!]] [·Three Applications {for cartons with 3 applicators}] and/or [3 Month Supply] or [12 Week Supply]] 

### [-Best ifused 

### year round!] [·Kills Fleas Up to [4 weeks!] [2 months] [3 months]] ['(ICON Showing 4 Week Protection)] [.4 Week Dose!] [,1 Month Dose!] ['Easy to Use Application] [-Specially Formulated for Dogs and Puppies] ['[Free] Calendar Stickers Inside!] 

### [-[Free] Brochure Inside!] [-[Free] Brochure and Calendar Stickers Inside] [·Patented Technology] [·Kills Flea Eggs & Flea Larvae for more than [63days], [9 weeks]!] 

### [-Prevents Flea Eggs From Developing Into Biting Adults] [·Kills Ticks for Up to [4 weeks]!] [-Kills [all stages of]Deer Ticks (vector ofLyme Disease) for up to 

### weeks] [-Kills Ticks (Including Deer Ticks) for up to 4 weeks] [·Kills [Brown], [American,] [and Lone Star ]Dog Ticks for up to 4 weeks; 

### [-Kills Rhipicephalus sanguineus 

### for up to 4 weeks] " . 

### [-When used monthly [brand name] completely breaks the flea life cy<:,(e**~Jd** 

### controls tick and chewing lice infestations.] [-Kills American Dog Ticks [(Dermacentor variabilis)] 

### for up to 4 weeks!] ['Apply once every [4 weeks]!] 

### [-4 week Flea and Tick Treatment!] [Once A Month Flea and Tick Treatment] [-Kills Fleas and Ticks for up to 4 weeks!] ['Kills all stages ofthe fIea life cycle] 

### [-Kills Fleas, Ticks, Flea Eggs & 

### Flea Larvae for up to 4 Weeks] ['[Kills mosquitoes]] 

### [-Dogs can be bathed 24 hours after**squeeze~on** 

### is applied] [-Prevents and controls reinfestations] [-[Free with purchase] [Free inside] Monthly Application Reminder [Magnet] [clip] [card]]

### 11 August 2010 Information in [ 

# Sergeant's® Master Label Version 10.1 EPA Reg. No. 25 17-XX 

## l is optional. Page 3 of8 [For Dogs & 

### Puppies (12 weeks or older and) up to 22 lbs.) [For Dogs 23-44lbs.[ )For Dogs 45-88 lbs.) [For Dogs 89-132 lbs.) 

## [ 1

- Denotes Optional Statements and/or Images that May be Used on Front, Back or Side Label Panels 

### [Ingredient Statement may be on front orback label] ACTIVE INGREDIENTS: 

### Fipronil 9.8% Pyriproxyfen (CAS# 95737-68-1) 2.0% OTHER INGREDIENTS: 88.2% TOTAL: 100.0% [Nylar® is a registered trademark ofMcLaughlin Gonnley King Company. U.S. Patent No. 5.942.525]
KEEP OUT OF REACH OF CHILDREN 

### WARNING See [Back] [or][Side] [Label Panel[s] [or] [insert] for Additional Precautionary Statements

NET CONTENTS: Contains (3) [0.023 

### fl oz] [0.67 ml) applicators Contains (3) [0.045 

### fl oz] [1.34 ml) applicators Contains (3) [0.091 

### fl oz] [2.68 ml] applicators Contains (3) [0.136 

### fl oz] [4.02 ml] applicators 11 August 2010 Information in [ 

# Sergeant's@ Master Label Version 10.1 EPA Reg. No. 25 17-XX 

## l is optional. Page 3 of8 [For Dogs & 

### Puppies (12 weeks or older and) up to 22 lbs.) [For Dogs 23-44lbs.[ )For Dogs 45-88 lbs.) [For Dogs 89-132 lbs.) 

## [ 1

- Denotes Optional Statements and/or Images that May be Used on Front, Back or Side Label Panels 

### [Ingredient Statement may be on front orback label] ACTIVE INGREDIENTS: 

### Fipronil 9.8% Pyriproxyfen (CAS# 95737-68-1) 2.0% OTHER INGREDIENTS: 88.2% TOTAL: 100.0% [Nylar® is a registered trademark ofMcLaughlin Gonnley King Company. U.S. Patent No. 5.942.525]
KEEP OUT OF REACH OF CHILDREN 

### WARNING See [Back] [or][Side] [Label Panel[s] [or] [insert] for Additional Precautionary Statements

NET CONTENTS: Contains (3) [0.023 

### fl oz] [0.67 ml) applicators Contains (3) [0.045 

### fl oz] [1.34 ml) applicators Contains (3) [0.091 

### fl oz] [2.68 ml] applicators Contains (3) [0.136 

### fl oz] [4.02 ml] applicators

### Version ID.l 

### Page 4 of8 

# Sergeant's® Master Label EPA Reg. No. 2517-XX ] is optional. 

### 1l August 2010 Information in [



### [BACK/SIDE CARTON LABEL

- MASTER LABEL] [brand name} contains fipronil and the insect growth regulator (IGR) Nylar®. to effectively kill] Fleas, Ticks [(including those that may transmit Lyme Disease)], and kills flea eggs, flea larvae, mosquitoes and (chewing) lice. The active ingredients in [brand name] work by 

### collecting in the hair follicles and skin oils. This product features a sustained-release formula that discharges from the animal's hair follicles using the natural skin oils, resulting in fast acting [and long lasting] control ofFleas and Ticks, [and kills mosquitoes] and chewing lice [for 30 

### days]. 

### [diagram with visual offipronil collecting and being released from hair follicle] READ ENTIRE LABEL BEFORE EACH USE. USE ONLY ON DOGS AND PUPPIES OVER 12 WEEKS OF AGE. PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS AND DOMESTIC ANIMALS. WARNING. Causes substantial but temporary eye injury. Do not get in eyes or on clothing. Wash thoroughly with 

### soap and water after handling and before eating, drinking, chewing gum, or using tobacco. Remove and 

### wash contaminated clothing before reuse. Harmful ifswallowed. Harmful ifabsorbed through skin. Prolonged orfrequently repeated skin contact may cause allergic reactions in some individuals. 

### FIRST AID

Ifln Eyes 

# • Hold eye open and rinse slowly and gently with water for 15-20 minutes. 

# • Remove contact lenses, ifpresent, afterthe first 5 minutes, then continue rinsing eye. 

# • Call a poison control center or doctor for further treatment advice. 

### HOn Skin 

# • Take offcontaminated clothing. 

### Or Clothing 

# • Rinse skin immediately with plenty afwater for 15-20 minutes. 

# • Call a poison control center or doctor for treatment advice. IfSwallowed 

# • Call a poison control center or doctor immediately for treatment advice. 

# • Have person sip a glass ofwater ifable to swallow. 

# • Do not induce vomiting unless told to do so by a poison control center or doctor. 

# • Do not g:ive anvthing: bv mouth to an unconscious oerson. 

### HOT LINE NUMBER Have the product container or label with you when calling a poison control center or doctor, or going for treatment. For more information on this pesticide product (including health concerns, medical emergencies or pesticide incidents), y011 may call 1-800-781-4738. 

### NOTE TO PHYSICIAN ORVETERINARIAN Treat patient symptomatically II August 2010 Information in [ ] is optional. 

# Sergeant's® Master Label Version ID.I EPA Reg. No. 2517-XX Page 4 of8

F.·R

..· ·.·.O.·.·

.·.'.N.·.·

·. .T.·

••·•·.· ·.' P.·

.. 

# ANEL. ·i·.iii.i.'.'.,··,·.,·.i:;.i, : ...•.•' .••

### ??

## i ...•..:
..'

..'.:.·

..,"·:.·.·.··,.·",,····,·,·,,·

# ,·,··....;',·,,",·'············',··,',···,::··::nOGSQ1.JEEZE·'·ON



# .. ...,'

..",

.., .., .., ...'.,,'

...,.'

.. , .....'.'.',.•...,.,'

...,.::•.,.,...:,.•, .•,·,·.."

....',','

..**i'···:~Ip;RQ:N"jU!fij¥LAR** [BACK/SIDE CARTON LABEL

- MASTER LABEL] [brand name] contains fipronil and the insect growth regulator (IGR) Nylar®. to effectively kill] Fleas, Ticks [(including those that may transmit Lyme Disease)], and kills flea eggs, flea larvae, mosquitoes and (chewing) lice. The active ingredients in [brand name] work by collecting in the hair follicles and skin oils. This product features a sustained-release formula that discharges from the animal's hair follicles using the natural skin oils, resulting in fast acting [and long lasting] control ofFleas and Ticks, [and kills mosquitoes] and chewing lice [for 30 days]. [diagram with visual offipronil collecting and being released from hair follicle]
READ ENTIRE LABEL BEFORE EACH USE. USE ONLY ON DOGS AND PUPPIES OVER 12 WEEKS OF AGE.
PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS AND DOMESTIC ANIMALS. WARNING. Causes substantial but temporary eye injury. Do not get in eyes or on clothing. Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, or using tobacco. Remove and wash contaminated clothing before reuse. Harmful ifswallowed. Harmful ifabsorbed through skin. Prolonged orfrequently repeated skin contact may cause allergic reactions in some individuals.
FIRST AID

IfIn E)'es 

# • Hold eye open and rinse slowly and gently with water for 15-20 minutes. 

# • Remove contact lenses, ifpresent, afterthe first 5 minutes, then continue rinsing eye. 

# • Call a poison control center or doctor for furthertreatment advice. HOn Skin 

# • Take offcontaminated clothing. Or Clothing 

# • Rinse skin immediately with plenty ofwater for 15-20 minutes. 

# • Call a poison control center or doctor fortreatment advice. H Swallowed 

# • Call a poison control center or doctor immediately for treatment advice. 

# • Have person sip aglass ofwater ifable to swallow. 

# • Do not induce vomiting unless told to do so by a poison control center or doctor. 

# • Do not give anything by mouth to an unconscious person. HOT LINE NUMBER Have the product container or label with you when calling a poison control center or doctor, or going for treatment. For more information on this pesticide product (including health concerns, medical emergencies orpesticide incidents), y011 may call 1-800-781-4738. NOTE TO PHYSICIAN OR VETERINARIAN Treat patient symptomaticallyVersion 10.1 Page 5 of8 

# Sergeant's® Master Label EPA Reg. No. 2517-XX 11 August 2010 Infonnation in [ ] is optional. 

### DIRECTIONS FOR USE It 

### is a violation ofFederal law to use this product in a manner inconsistent with its labeling. READ ENTIRE LABEL [AND ENCLOSED DIRECTIONS] BEFORE EACH USE.
DO NOT USE ON CATS. May be toxic and potentially fatal ifapplied to or ingested by cats. FOR EXTERNAL USE ON DOGS ONLY. Do not use on puppies under 12 weeks ofage. Weigh your dog to be sure you are applying the right dose formulated for the weight ofyour pet. Do not treat yourpet with more than one pesticide product at a time. Over dosing your animal 

### can result in serious illness and even death. Best if

### used year round. Certain medications can interact 

### with pesticides. Consult a veterinarian before using this product on debilitated, aged, medicated, pregnant, or nursing dogs. Consult a veterinarian before using on dogs with known organ dysfunction. DO NOT USE ON CATS or animals other than dogs. Separate the treated dog from all other dogs and cats for 24 hours after treatment has been applied. Cats and dogs that actively groom or engage in close physical contact with treated dog may be at risk ofserious harmful effects. The most common signs ofingestion are excessive salivation and foaming at the mouth. Ifthese symptoms occur immediately feed your dog and continue to monitor your pet for the next 24 hours. Ifsymptoms persist call 1-800-781-4738 to talk to a veterinarian. Cats exhibiting these same symptoms from ingestion should be taken to the veterinarian immediately. Ifyour dog is exhibiting signs ofand/or are being treated for skin dermatitis, talk to your vet before applying any topical flea and tick control product. Sensitivities may occur after using ANY pesticide product on pets. Ifsigns ofsensitivity occur bathe your dog with a mild soap and rinse with large amounts ofwater. Ifsigns continue, consult a veterinarian immediately by calling 1-800-781-4738. [{Outer Packaging or Insert Copy}] How to open: Remove producttubes [vial] from the package. Separate one tube from the others. Holding the tube [vial] with notched end pointing up and away from the face and body, cut off the narrow end at the notches with scissors.
How to apply: Inverttube over dog and use open end to part dog's hair. Squeeze tube firmly to apply all ofthe solution to the dog's skin, as directed below. Repeat application may be made if necessary, but do not apply more often than once every 4 weeks. 

### FREQUENCY OF APPLICATION Use [brand name] monthly for complete control offlea, tick [and] chewing lice [and to kill mosquitoes] [infestations]. [Studies show that] [brand name] kills fleas for up to three months. Ifyourpet is at high risk for flea reinfestation [, orin a highly infested environment], apply monthly. Apply monthly to control ticks, mosquitoes and chewing lice. [Brand name] kills mosquitoes within 24 hours for the first 7 days after treatment, then within 48 hours for up to 28 days. [Brand name] remains effective, even afterbathing, water immersion, or exposure to sunlight. Allow treated area to dry thoroughly. Do notreapply for 30 days. Version 10.1 Page 5 of8 

# Sergeant's® Master Label EPA Reg. No. 2517-XX 11 August 2010 Infonnation in [ ] is optional. 

### DIRECTIONS FOR USE It 

### is a violation ofFederal law to use this product in a manner inconsistent with its labeling. READ ENTIRE LABEL [AND ENCLOSED DIRECTIONS] BEFORE EACH USE.
DO NOT USE ON CATS. May be toxic and potentially fatal ifapplied to or ingested by cats. FOR EXTERNAL USE ON DOGS ONLY. Do not use on puppies under 12 weeks ofage. Weigh your dog to be sure you are applying the right dose formulated for the weight ofyour pet. Do not treat yourpet with more than one pesticide product at a time. Over dosing your animal 

### can result in serious illness and even death. Best if

### used year round. Certain medications can interact 

### with pesticides. Consult a veterinarian before using this product on debilitated, aged, medicated, pregnant, or nursing dogs. Consult a veterinarian before using on dogs with known organ dysfunction. DO NOT USE ON CATS or animals other than dogs. Separate the treated dog from all other dogs and cats for 24 hours after treatment has been applied. Cats and dogs that actively groom or engage in close physical contact with treated dog may be at risk ofserious harmful effects. The most common signs ofingestion are excessive salivation and foaming at the mouth. Ifthese symptoms occur immediately feed your dog and continue to monitor your pet for the next 24 hours. Ifsymptoms persist call 1-800-781-4738 to talk to a veterinarian. Cats exhibiting these same symptoms from ingestion should be taken to the veterinarian immediately. Ifyour dog is exhibiting signs ofand/or are being treated for skin dermatitis, talk to your vet before applying any topical flea and tick control product. Sensitivities may occur after using ANY pesticide product on pets. Ifsigns ofsensitivity occur bathe your dog with a mild soap and rinse with large amounts ofwater. Ifsigns continue, consult a veterinarian immediately by calling 1-800-781-4738. [{Outer Packaging or Insert Copy}] How to open: Remove producttubes [vial] from the package. Separate one tube from the others. Holding the tube [vial] with notched end pointing up and away from the face and body, cut off the narrow end at the notches with scissors.
How to apply: Inverttube over dog and use open end to part dog's hair. Squeeze tube firmly to apply all ofthe solution to the dog's skin, as directed below. Repeat application may be made if necessary, but do not apply more often than once every 4 weeks. 

### FREQUENCY OF APPLICATION Use [brand name] monthly for complete control offlea, tick [and] chewing lice [and to kill mosquitoes] [infestations]. [Studies show that] [brand name] kills fleas for up to three months. Ifyourpet is at high risk for flea reinfestation [, orin a highly infested environment], apply monthly. Apply monthly to control ticks, mosquitoes and chewing lice. [Brand name] kills mosquitoes within 24 hours for the first 7 days after treatment, then within 48 hours for up to 28 days. [Brand name] remains effective, even afterbathing, water immersion, or exposure to sunlight. Allow treated area to dry thoroughly. Do notreapply for 30 days.Version 10.1 Page 6 of8 

# sergeant's® Master Label EPA Reg. No. 25l7-XX 

## I is optional. 11 August 2010 Information in [


### For Dogs Weighing up to 221bs. {For cartons containing .67ml (0.023 fl. 

### oz.) applicator tubes} Apply one tube (.67ml)(0.023 

### fl. oz.) [as a spot to the dog's back between the shoulder blades] [from the back ofthe neck to apoint midway between the neck and tail]. 

### ForDogs Weighing Between 23-44 lbs. {For cartons containing 1.34 ml (0.045 

### fl. oz.) applicator tube} [Apply two tubes (.67ml)(0.023 

### fl. oz.) as a spot on the dog's back between the shouider] [or] [Apply one tube (1.34 ml)(0.045 

### fl. oz.) as a spot to the dog's back between the shouider blades.] 

### ForDogs Weighing Between 45-88Ibs. For cartons containing 2.68 ml (0.091 

### fl. oz.) applicator tube} Apply one tube (2.68 mi)(0.09l 

### fl. oz.) [as a spot on the dog's back between the shoulder] [from the back ofthe neck to apointmidway between the neck and tail].
For Dogs Weighing 89-132Ihs For cartons containing 4.02ml (0.136 

### fl. oz.) applicatortube} Apply one tube (4.02 ml)(0.136 

### fl. oz.) [as a spot on the dog's back between the shoulder] [from the back ofthe neckto a point midway between the neck and tail].

STORAGE AND DISPOSAL PESTICIDE STORAGE: Do not remove tube from the pack until ready to use. Store in a cool [below 7rF (2S"C)] dry place inaccessible to children and pets. Do not refrigerate. Protectfrom direct sunlight. PESTICIDE DISPOSAL AND CONTAINER HANDLING: Non-refillable container. Do not reuse or refill this container. Ifempty: Place in trash or offerfor recycling ifavailable. Ifpartly filled: Call your local solid waste agency for disposal instructions. Never place unused product down any indoor or outdoor drain. [WARRANTY Read the entire Directions for Use and Warranty before using this Product. By using this product, user or buyer accepts the following warranty. ([The directions for use ofthis product are believed to adequate and must be followed carefully. It is impossible to eliminate all risks associated with the use ofthis product. Unintended consequences may result because ofunknown factors. All such risks shall be assumed by the user or buyer.] 

### I Sergeant's is committed to providing high quality products. To the extent consistent with applicable law, Sergeant's makes no warranties, express or implied, of merchantability or offitness for a particular purpose or otherwise, that extend beyond statements Oll this label. To the extent consistent with applicable law, Sergeant's, the manufacturer, or the Seller shall not be liable for indirect, special, incidental or consequential damages. To the extent consistent with applicable law, the exclusive remedy ofthe user orbuyer shall not exceed the purchase price paid.] [Ifyou have questions or comments aboutthis product, please write: Sergeant's Consumer Response, P.O. Box 540399, Omaha. NE 68i54-0399.]
In Case ofEmergency, call: 1-800-781-4738 [For more information] [Visitus at:] [www.sergeants.com] Non-Emergency callJ-800-224-PETS (7387) [Made in USA] Version 10.1 Page 6 of8 

# sergeant's® Master Label EPA Reg. No. 25l7-XX 

## I is optional. 11 August 2010 Information in [


### For Dogs Weighing up to 221bs. {For cartons containing .67ml (0.023 fl. 

### oz.) applicator tubes} Apply one tube (.67ml)(0.023 

### fl. oz.) [as a spot to the dog's back between the shoulder blades] [from the back ofthe neck to apoint midway between the neck and tail]. 

### ForDogs Weighing Between 23-44 lbs. {For cartons containing 1.34 ml (0.045 

### fl. oz.) applicator tube} [Apply two tubes (.67ml)(0.023 

### fl. oz.) as a spot on the dog's back between the shouider] [or] [Apply one tube (1.34 ml)(0.045 

### fl. oz.) as a spot to the dog's back between the shouider blades.] 

### ForDogs Weighing Between 45-88Ibs. For cartons containing 2.68 ml (0.091 

### fl. oz.) applicator tube} Apply one tube (2.68 mi)(0.09l 

### fl. oz.) [as a spot on the dog's back between the shoulder] [from the back ofthe neck to apointmidway between the neck and tail].
For Dogs Weighing 89-132Ihs For cartons containing 4.02ml (0.136 

### fl. oz.) applicatortube} Apply one tube (4.02 ml)(0.136 

### fl. oz.) [as a spot on the dog's back between the shoulder] [from the back ofthe neckto a point midway between the neck and tail].

STORAGE AND DISPOSAL PESTICIDE STORAGE: Do not remove tube from the pack until ready to use. Store in a cool [below 7rF (2S"C)] dry place inaccessible to children and pets. Do not refrigerate. Protectfrom direct sunlight. PESTICIDE DISPOSAL AND CONTAINER HANDLING: Non-refillable container. Do not reuse or refill this container. Ifempty: Place in trash or offerfor recycling ifavailable. Ifpartly filled: Call your local solid waste agency for disposal instructions. Never place unused product down any indoor or outdoor drain. [WARRANTY Read the entire Directions for Use and Warranty before using this Product. By using this product, user or buyer accepts the following warranty. ([The directions for use ofthis product are believed to adequate and must be followed carefully. It is impossible to eliminate all risks associated with the use ofthis product. Unintended consequences may result because ofunknown factors. All such risks shall be assumed by the user or buyer.] 

### I Sergeant's is committed to providing high quality products. To the extent consistent with applicable law, Sergeant's makes no warranties, express or implied, of merchantability or offitness for a particular purpose or otherwise, that extend beyond statements Oll this label. To the extent consistent with applicable law, Sergeant's, the manufacturer, or the Seller shall not be liable for indirect, special, incidental or consequential damages. To the extent consistent with applicable law, the exclusive remedy ofthe user orbuyer shall not exceed the purchase price paid.] [Ifyou have questions or comments aboutthis product, please write: Sergeant's Consumer Response, P.O. Box 540399, Omaha. NE 68i54-0399.]
In Case ofEmergency, call: 1-800-781-4738 [For more information] [Visitus at:] [www.sergeants.com] Non-Emergency callJ-800-224-PETS (7387) [Made in USA]Version 10.1 Page 7 of8 

# Sergeant's® Master Label EPA Reg. No. 2517-XX ] is optionaL II August 2010 Information in [
Distributed by: Sergeant's Pet Care Products, Inc. P.O. Box 540399 Omaha, NE 68154-0399 EPA Reg. No. 2517-XX EPA Est. No. XXXXX-XX-XXX [BAR CODE AREA]

IOptionallnsert or package copy] IHow to Apply

- May contain graphics illustrating product use, e.g., dog with a drop 

### falling onto its neck from a vial on front, side, or back carton label and/or applicator labeling.[ [{Outer Packaging or Insert Copy}]
How to open 

### 1. Remove product tubes 

### [vial} from the package. 2. Separate one tube from the others. Holding the tube 

### [vial] with notched end pointing up and away from the face and body, cut offthe narrow end at the notches with scissors. 

### How to apply: 1. Invert tube over dog and usc open end to part dog's hair. 2. Squeeze tube firmly to apply all ofthe solution to the dog's skin las a spot to the dog's back between the shoulder blades.] [or] [fromthe backofthe neck to a point midway between the neck and tail.] 

### {Flea life cycle diagram] [Look at the Label (Look atthe Label icon) 6 Step [Easy] [Spot On] [Squeeze-On] [Topical] Checklist

• Read the label completely and follow directions

• Weigh your pet

• Do NOT use Dog products on Cats

• Do NOT treat with more than one pesticide product at atime

• Separate animals aftertreatment to avoid chance ofingestion

• Do NOT splittubes between pets] [Brand Name] [Monthly reminder card] IApply [Brand Name] monthly for continuous protection against Fleas, Ticks, [and] chewing lice Iand mosquitoes].] [Pet's Name (Empty blank for owner to fill in name)] [First [dose] [Treannent] (Empty blank for ownerto fill in date)] [Second [dose] [Treatment] (Empty blank for ownerto fill in date)] [Third [dose] [Treatment] (Empty blankfor ownerto fill in date)] [calendar stickers with brand name] IPlace stickers on your calendar as a reminder to reapply [brand name] [in 30 days.] Version 10.1 Page 7 of8 

# Sergeant's® Master Label EPA Reg. No. 2517-XX ] is optionaL II August 2010 Information in [
Distributed by: Sergeant's Pet Care Products, Inc. P.O. Box 540399 Omaha, NE 68154-0399 EPA Reg. No. 2517-XX EPA Est. No. XXXXX-XX-XXX [BAR CODE AREA]

IOptionallnsert or package copy] IHow to Apply

- May contain graphics illustrating product use, e.g., dog with a drop 

### falling onto its neck from a vial on front, side, or back carton label and/or applicator labeling.[ [{Outer Packaging or Insert Copy}]
How to open 

### 1. Remove product tubes 

### [vial} from the package. 2. Separate one tube from the others. Holding the tube 

### [vial] with notched end pointing up and away from the face and body, cutoffthe narrow end at the notches with scissors. 

### How to apply: 1. Invert tube over dog and usc open end to part dog's hair. 2. Squeeze tube firmly to apply all ofthe solution to the dog's skin las a spot to the dog's back between the shoulder blades.] [or] [fromthe backofthe neck to a point midway between the neck and tail.] 

### {Flea life cycle diagram] [Look at the Label (Look atthe Label icon) 6 Step [Easy] [Spot On] [Squeeze-On] [Topical] Checklist

• Read the label completely and follow directions

• Weigh your pet

• Do NOT use Dog products on Cats

• Do NOT treat with more than one pesticide product at atime

• Separate animals aftertreatment to avoid chance ofingestion

• Do NOT splittubes between pets] [Brand Name] [Monthly reminder card] IApply [Brand Name] monthly for continuous protection against Fleas, Ticks, [and] chewing lice Iand mosquitoes].] [Pet's Name (Empty blank for owner to fill in name)] [First [dose] [Treannent] (Empty blank for ownerto fill in date)] [Second [dose] [Treatment] (Empty blank for ownerto fill in date)] [Third [dose] [Treatment] (Empty blankfor ownerto fill in date)] [calendar stickers with brand name] IPlace stickers on your calendar as a reminder to reapply [brand name] [in 30 days.]

### II August 2010 Information in [ 

# Sergeant's@ Master Label Version 10.1 EPA Reg. No. 2517-XX 

## I is optional. Page 8 of8 [Monthly Application Reminder Magnet (image ofreminder magnet) Enclosed for your convenience is an application reminder magnet. Push the (reset) button to start 

### the clock. After 30 days the magnet will flash (and beep) reminding you to reapply [Brand Narne]. 

### This application reminder can be used for future treatments. Just press the reset button and in another 30 days the reminder magnet will flash (and beep) reminding you to reapply.]


### {END

- OPTIONAL INSERT OR PACKAGE COPY} 

### TUBE IVIAL LABEL Front Label 

### Back Label {Brand Name} Fipronil 9.8%, Pyriproxyfen 2.0% Dog 0.67 mL (or) 1.34 mL (or) 2.68 mL (or) 4.02 mL {label code} KEEP OUT OF REACH OF CHILDREN WARNING: Read directions and precautions before using. Use scissors to open. EPA REG. No. 2517-XX {label code} [Optional: Example pictograms that mayor may not be found on the printed label] 

### 11 August 2010 Information in [ 

## 1is optional. 

# Sergeant's® Master Label Version 10.1 EPA Reg. No. 2517-XX Page 8 of8 [Monthly Application Reminder Magnet (image ofreminder magnet) Enclosed for your convenience is an application reminder magnet. Push the (reset) button to start the clock. After 30 days the magnet will 

### flash (and beep) reminding you to reapply [Brand Narne]. This application reminder can be used for future treatments. Just press the reset button and in another 30 days the reminder magnet will 

### flash (and beep) reminding you to reapply.]


### {END

- OPTIONAL INSERT OR PACKAGE COPY}

### ~g'I'Y~'PI.iAJ~gJP Front Label Back Label {Brand Name} Fipronil 9.8%, Pyriproxyfen 2.0% Dog 0.67 mL (or) 1.34 mL (or) 2.68 mL (or) 4.02 mL {label code} KEEP OUT OF REACH OF CHILDREN WARNING: Read directions and precautions before using. Use scissors to open. EPA REG. No. 2517-XX {label code} [Optional: Example pictograrns that mayor may not be found on the printed label]!5 Dccember**~009** Richard Ccbkell Product**I'vl~ll1ager** 22 j)octll1lent**Proeesslll~** Desk on!:.::e n

### rPesticide Progr:llns U,S, EllVil'olllno.:ntal Pwkdillfl AgellC}' RU(l(l1**S~49()(),** (Jile P(llulll,H':: '{,elrel 2777 Snulll Crystall)ri\'c Arlillglllll. \/A 22202-4S0 I
Dear 1vl1", Gehken: Sergeant's Pet Care Products, Inc.

Sergeant'!; Pel Cnre Products. Inc. (Sergeant's. 2625 SoutillSgil' Plaza, Om,lIHl. Nehraska 6S 130-1770. EPA Cmnpany Number 25 J7), aUlhnrizes Expnncm, Inc. {II 50 Connectieul Avenue, NW, Suite 1100, Washington DC, 20(36) In n(;t nn our heh,lIL as nul' Authorizcd Representative, f()]' £III necessary inleractions regarding all ofnul' pmduct n:gistnnion applicntions and registnninns. Plcase note lhis daes I1nl change the eurrenl flied Allllwrized Agem**1~1r** Sergeant's,
The ExpnncnL Inc. contnct is £IS t(dlows:

J<lI11CS Messin,1 and/or Rick Tills\(.'orih Exponcnt. Inc. I 150 Cunnecticut ;\VC" NW Suitc II UO \\/ashingion, DC 20036 (202) 772-4932 (202) 772-4979 fax j mess111 i1 ({(CXpUlleniXo!n'reiIISW (}rt11 (O):XpOllent.co111 !r )\1\1 hmc ,Hly <jucs,inll.s..**pieii~e** conine; me ai 402--9}8-7079

# /r;;~ j 10- Kelly R. Hoskins \;bnilgcr ofTechllicill An:1irs

co.:: .!:Jmcs**rVlc~sin,l** !5 Dccember**~009** Richard Ccbkell Prod(lct I'vl**~ll1ager** 22 j)octll1lent Proeesslllg Desk on!:.::e n

### rPesticide Progr:llns U, S, EllVi l'OIIln0.:])taI Prokdilin AgellC)' Run (l1**S~49()(),** (Jile Pm Gill ,Ii':: '{ ,elrel 2777 Snulll Crystal I)rl\'c Arlill£,lulL \/A 22202-450 I
Dear 1vl1", Gehken: Sergeant's Pet Care Products, Inc.

Sergeant\; Pel Cnre Produds. Inc. (Sergeant's. 2625 South 15gil' 

### rlaza, Om,lIHl. Nehraska 6S 130-1 770, EPA Cmnpany Nlimbel' 25 J7), aUlhnrizes Expnnem, Inc. ( I I50 ConnediCUI Avenue, NW, Suite I 100, Washington DC 20(36) In n(;t nn our heh,lIL as nul' Authorizcd Representative, f()]' £III necessary inleractions regarding 

### all ofnul' pmduct n:gistnnion applicntions and registnninns. Plcase note lhis daes nnl change the eurrenl fj led Allllwrized Agelll**I~)r** Sergeant's, The ExpnncnL Inc. contnct is £IS t(dlows: J<lmcs Messin,) and/or Rick Tills\(.'orih Exponcnt. Inc. I150 Cunnecticut ;\VC" N\V Suitc II UO \\/ashington, DC 20036 (202) 772-4932 (202) 772-4979 fax j meSSllli1(t(C\ pUllcni xo!I1'rtinswort1!(O).':xpOllen[.cOll1 !

### r)\1\1 hmc cHlY <jucs,inlls. piense conine; me ai 402--9}8-7079. Sincerely.

co.:: .!:Jmcs tv-lessin,]sergeant's Pet Care Products, Inc. 2625 South 158th Plaza • Omaha, NE**68130~1770** • Telephone 402.938.7000 • Fax402.938.7091 • www.sergeams.com 

### August 11, 2010 Richard Gehken, PMIO Office o[Pesticide Programs (7504P) (REGFEE) 

### U.S. Environmental Protection Agency Document ProcessingDesk Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202 

### Subject: Submission ofEPAPesticide Registration ImprovementActInformation Dear Mr. 

### Gebken: Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 158'" Plaza, Omaha, NE 68130-1770, 

### EPA CompanyNumber 2517), is submittingPesticide Registration ImprovementAct Information for the following new registration application:

• Sergeant's Fipronil 

### + Nylar**Squeeze~On** 

### for Dogs R310, $4,578 (50% fee waiver 82,289), Pay.gov Tracking 1D: 25101L1D, Agency Tracking 1D: 74122352206. 

### This registration application is for a new end-use productwith supporting data and is considered an R310, new end-use product, requires review ofdata package within RD, PRIA review time frame 6months, and a fee of$4,578. Sergeant1s qualifies for aPRIA fee waiver/reduction of 50% (referto opp 

### Decision NumberD-425455). Ifyou have any questions or need additional information regarding this registration application, please contactme at402-938-7079. 

### Sincerely,



# 1l-&r**~.** HoslA.N

# I~I Kelly R. Hoskins 

### Manager ofTechnical 

### Affairs sergeant's Pet Care Products, Inc.

2625 South 158th Plaza • Omaha, NE**68130~1770** • Telephone 402.938.7000 • Fax402.938.7091 • www.sergeams.com 

### August 11,2010 Richard Gebken, PMI0 Office ofPesticide Programs (7504P) (REGFEE) U.S. Environmental Protection Agency Document Processing Desk Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202 Subject: Submission ofEPA Pesticide Registration ImprovementActInformation DearMr. Gebken: Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 158tit 

### Plaza, Omaha, NE 68130-1770, EPA CompanyNumber 2517), is submitting Pesticide Registration ImprovementAct Information for the following new registration application:

• Sergeant's Fipronil 

### + Nylar**Squeeze~On** 

### for Dogs R310, $4,578 (50% fee waiver $2,289), Pay.gov Tracking ID: 2510ILID, Agency Tracking ill: 

### 74122352206. This registration application is for a new end-use productwith supporting data and is considered an R310, new end-use product, requires review ofdatapackage within RD, PRIAreview time frame 6 months, and a fee of$4,578. Sergeant1s qualifies for a PRIA fee waiver/reduction of 50% (referto OPP Decision NumberD-425455). Ifyou have any questions or need additional informationregarding this registration application, please contactme at402-938-7079. Sincerely,



# 1L&r

< 

# HoslA.N

# !~I Kelly R. Hoskins Manager ofTechnical AffairsVoluntary Small Business Certification Form for Pesticide Registration Fee WaiverlReduction
Section 1: Business Identification 

### Company Name: Sergeant's Pet Care Products, Inc. 

### Address: 2625 South 158"' Plaza Omaha, NE 68130-1770 EPA Company Number: 2517 ContactName: 

### Kelly R. Hoskins Manager 

### ofTechnical Affairs 

### Phone Number: 402-938-7079 Fax Number: 402-938-7091 Email: 

### KHoskins(ii)SERGEANTS.com Section 2: EPA Pendini! Action Identification Product Name: Sergeant's Fipronil 

### +Nylar Squeeze-On for 

### Dogs Descrintion ofAction Submitted to EPA: New end-use productwith efficacy data 

### EPA Identification 2517-NEW EPAFee Category and Fee EPA PRIA fee category R31 0, 6 month review, $4,578 (50% fee waiver $2,289) Section 3: Small Business InformationIDocumentation Fee Waiver Support as a Small Business (as 

### Yes, 50%. applicable): Is the Applicant abusiness entity with one or No. Refer to previously filed request ofDmore affiliates? 

### 425455 (May 4, 2010) Business structure: include a chart or statement Refer to previously filed request ofDdescribing the applicant's business entity, its 

### 425455 (May4,2010) relationships to parent/owner company(s) and/or 

### affiliate company(s), and the percentage interest ofeach owner/affiliate. 

### Includingparent and affiliate(s), the applicant's 

### ( ) $10 million/year (75% fee waiver) average annual global gross revenue from 

### (x) $60 million/year (50% fee waiver) pesticides for the last 3 years was less than or 

### equal to: Documentation: Include revenue statements for Refer to previously filed request ofDthe Applicant showing annual global gross 

### 425455 (May 4, 2010) revenue from pesticides for each ofthe three most recent comnleted fiscal or tax vears. 

### Applicant's ( ) fiscal year (x) tax year ends on: September 30 Applicant's Audited Financial Statements are 

### January 31 available on/about: Does the Applicant now employ 500 or fewer 

### Yes emnlovees? Documentation: include the most recent IRS 941 Refer to previously filed request ofDor W3 or other official documentation 

### 425455 (May4, 2010) Voluntary Small Business Certification Form for Pesticide Registration Fee WaiverlReduction
Section 1: Business Identification 

### Company Name: Sergeant's Pet Care Products, Inc. 

### Address: 2625 South 158"' Plaza Omaha, NE 68130-1770 EPA Company Number: 2517 ContactName: 

### Kelly R. Hoskins Manager 

### ofTechnical Affairs 

### Phone Number: 402-938-7079 Fax Number: 402-938-7091 Email: 

### KHoskins(ii)SERGEANTS.com Section 2: EPA Pendini! Action Identification Product Name: Sergeant's Fipronil 

### +Nylar Squeeze-On for 

### Dogs Descrintion ofAction Submitted to EPA: New end-use productwith efficacy data 

### EPA Identification 2517-NEW EPAFee Category and Fee EPA PRIA fee category R31 0, 6 month review, $4,578 (50% fee waiver $2,289) Section 3: Small Business InformationIDocumentation Fee Waiver Support as a Small Business (as 

### Yes, 50%. applicable): Is the Applicant abusiness entity with one or No. Refer to previously filed request ofDmore affiliates? 

### 425455 (May 4, 2010) Business structure: include a chart or statement Refer to previously filed request ofDdescribing the applicant's business entity, its 

### 425455 (May4,2010) relationships to parent/owner company(s) and/or 

### affiliate company(s), and the percentage interest ofeach owner/affiliate. 

### Includingparent and affiliate(s), the applicant's 

### ( ) $10 million/year (75% fee waiver) average annual global gross revenue from 

### (x) $60 million/year (50% fee waiver) pesticides for the last 3 years was less than or 

### equal to: Documentation: Include revenue statements for Refer to previously filed request ofDthe Applicant showing annual global gross 

### 425455 (May 4, 2010) revenue from pesticides for each ofthe three most recent comnleted fiscal or tax vears. 

### Applicant's ( ) fiscal year (x) tax year ends on: September 30 Applicant's Audited Financial Statements are 

### January 31 available on/about: Does the Applicant now employ 500 or fewer 

### Yes emnlovees? Documentation: include the most recent IRS 941 Refer to previously filed request ofDor W3 or other official documentation 

### 425455 (May4, 2010)

### Section 4: Certification Statement I, Joe Connealy, the Vice President ofFinance (title), ofthe above-named Applicant, am authorized and have personal knowledge sufficient to make this certification onbehalfofthis Applicant. Ihereby certify underpenalty ofperjury that the information in Sections 1-3 above and the documentation submitted and/orrelied on in connection with this Applicant's Fee WaiverlReduction request are true, complete, and correct in all material respects, and accurately represent the currentbusiness status ofthis Applicant.

Joe Connealy 

# o£= -l(. 

## 7.olo Date Section 4: Certification Statement I, Joe Connealy, the Vice President ofFinance (title), ofthe above-named Applicant, am authorized and have personal knowledge sufficient to make this certification onbehalfofthis Applicant. Ihereby certify underpenalty ofperjury that the information in Sections 1-3 above and the documentation submitted and/orrelied on in connection with this Applicant's Fee WaiverlReduction request are true, complete, and correct in all material respects, and accurately represent the currentbusiness status ofthis Applicant.

Joe Connealy 

# o£= -ll. 

## 7.olo Date